The MA will be responsible for the day to day running of the Ghent office as well as providing administrative support to the Ghent based leadership team and Board of Directors.

Key Responsibilities:

Management Assistant

• Central support point of contact for the Ghent office;
• Responsible for reception/phone calls, logistical organisation of meetings, purchasing of supplies, coordination cleaning and maintenance etc;
• Provide overall administrative and organizational support (contract management, prepare presentations, travel, expense reimbursement, etc.);
• Practical and organizational preparation and follow-up of meetings and files;
• Practical organization of Executive and Board meetings and take care of all logistical facilities during these meetings (meeting room, lunch, diner, hotel, travel, etc.);
• You organize overall corporate meetings, trainings and/or events together with the HR team;
• Management of the travel & agenda of our CEO & CFO in order to ensure efficient planning of activities;
• Printing, binding and simple editing of documents.

Office Management

• Coordinate office activities and operations to secure efficiency and compliance with company policies;
• Taking care of inbound and outbound correspondence for the Ghent office (e-mail, letters, packages etc.);
• Manage phone calls and visitors (including tidying of meeting rooms);
• Track stocks of office supplies and place orders when necessary;
• Assist colleagues whenever necessary;
• You are the point of contact for all providers (food, cleaning, etc.).

Key requirements:

• Strong organizational skills (able to successfully handle multiple tasks at the same time and to prioritize);
• Strong communication & interpersonal skills;
• Critical thinking skills;
• Professional, dedicated & hardworking;
• Able to handle strict confidentiality with a high degree of professional & organizational maturity;
• Proactive, able to take initiatives & flexible;
• Stress-resistant (able to work towards deadlines efficiently).

Required Education / Experience:

• Bachelor degree in Office Management/Languages or you have relevant experience;
• Proven experience of a least 2 years as a Management Assistant, Executive Assistant;
• You are a good communicator and you are fluent in Dutch, French and English;
• [Very] good knowledge of Microsoft Office.

If you are interested, please send your resume and motivation to careers@dev.sequanamedical.com

Apply now

As a demand and supply planner, you cooperate closely with the sales, manufacturing and supply teams to ensure high service level by availability of products at optimal inventory levels with maintaining good forecast accuracy and low forecast bias. You build the cross functional interface between sales organization, manufacturing and supply chain to include changes in demand into the supply forecast and give visibility for the entire process of components sourcing through production forecasting and roll out of finalized products into the market. You support the supply chain director and production manager for the material availability for production and logistics of the alfapump®, an implantable Medical Device for the automatic and continual removal of ascites in patients with liver disease.

To be able to master this challenge, you keep a professional and open relationship to multiple key internal stakeholders, collaborating closely with internal departments to ensure availability of the material in a timely manner.

You are part of the Manufacturing/Supply Chain department, which is crucial to guarantee product availability on commercial markets and in clinical trials.

Key Responsibilities:

• Master data management;
• Interact with internal teams and sales divisions to understand demand forecast drivers and to determine production demand;
• Plan production runs and schedules according to internal and external demand;
• Develop and review production plan with Manufacturing/Supply Chain leadership;
• Monitor execution of production plan and work with manufacturing team to resolve potential issues in a timely fashion;
• Plan inventory management process to avoid shortages;
• Monitor execution of inventory management and work with supply chain team to resolve potential issues in a timely fashion;
• Escalate complex issues to Manufacturing/Supply Chain leadership for resolution;
• Plan material requirements to execute manufacturing plan;
• Provide project management support for the function;
• Coordinate with Managers in planning and implementing inventory-related changes in production;
• KPI tracking and improvement (service level, forecast accuracy, etc.);
• Bachelor’s degree in Supply Chain Management, Business Management, or related field is preferred.;
• Proven experience as a demand and supply planner;
• PExperience working in highly regulated environments: healthcare (pharma/medical devices), food, …
• Experience in material requirements planning (MRP);
• Working knowledge of MS Office and ERP systems;
• Project management experience a plus;
• Analytical and logical thinking;
• Very good numerical and analytical skills (maths and statistics);
• Detailed oriented with high level of accuracy and problem-solving skills;
• Effective communication skills;
• Proficient oral and written skills in German and English;
• Team player who takes a flexible approach to the role within the team and works effectively with a variety of different groups, employees and managers.

Required Education / Experience:

• Technical degree with further education in purchasing, supply chain or similar, Project Management;
• 5 years of experience as a planner or project manager in a technical environment and/or supply chain;
• Relevant experience with Supplier Relationship Management and ERP systems;
• Work experience in a highly regulated industry (Medical Device, GMP, FDA, ISO 13485) is a plus.

If you are interested, please send your resume and motivation to careers@dev.sequanamedical.com

Apply now

The IT System Administrator needs to ensure the proper functioning of existing IT infrastructures, to maintain them and to make them evolve according to the needs and new technical solutions.

Key Responsibilities:

• Responsible for the maintenance, configuration, and reliable operation of computer systems, network servers, and virtualization together with the supporting companies;
• Install and upgrade computer components and software, manage virtual servers, and integrate automation processes;
• Troubleshoot hardware and software errors by running diagnostics, documenting problems and resolutions, prioritizing problems, and assessing impact of issues;
• Provide documentation and technical specifications to IT staff for planning and implementing new or upgrades of IT infrastructure;
• Maintain the regular backup operations and implement appropriate processes for data protection, disaster recovery, and failover procedures;
• Provide second level support and backup for the first level support team;
• Solid English spoken and written, German is a plus;
• 3-5 years network or system administration experience;
• System administration and IT certifications in Linux, Microsoft, or other network related fields are a plus;
• Working knowledge of VMWare and Veeam;
• Strong knowledge of systems and networking software, hardware, and networking protocols;
• Knowledge of implementing helpdesk and IT operations best practices, including working knowledge of security, storage, data protection, and disaster recovery protocols.

Required Education / Experience:

• Associate or Bachelor’s degree in Computer Science, Information Technology, System Administration, or a closely related field, or equivalent experience required.;

If you are interested, please send your resume and motivation to careers@dev.sequanamedical.com

Apply now

The Procurement Manager/Director is responsible for the procurement of goods and services for Sequana Medical NV and its subsidiaries. The duties include management of each part of the supply chain to ensure consistent delivery of goods and services while identifying possible obstacles that may affect supply or productivity. Furthermore, the Manager Procurement works with the team on complex projects and initiatives, selection and qualification of vendors, evaluation of bids, and negotiates prices and terms for purchased goods and services. This role is for procurement professionals that have the ability to combine developing the function while leading in the execution by example. You will be responsible for the leadership of the purchasing team; including employee promotion and development.

Key Responsibilities:

General Duties and Responsabilities

• Manages all purchasing functions and established strategic purchasing processes and procedures;
• Establishes strategy and best practices to ensure achievement of overall business objectives;
• Works with internal customers to identify and address unmet needs that align with procurement and business/capability goals to deliver long term value;
• Collaborates with cross-functional teams implementing sourcing initiatives and strategies;
• Works with vendors to establish supplier agreements and contracts;
• Studies market prices and trends to assist in suppler negotiation and performance;
• Negotiate the best pricing possible and ensure that orders received adhere to supplier agreements and contracts;
• Develops, implements, and maintains a supplier relationship and evaluation process to measure effective supplier performance and compliance;
• Gathers and analyses data to present solutions for a wide range of business opportunities;
• Actively seeks support from other departments to ensure procurement projects/requirements are completed in appropriate timeframes.

Team Planning:

• Continuously reviews and maintains team structure and balance across the supplier portfolio and activities;
• Plans the overall activities and leads the Procurement team;
• Provides input to strategic decisions that affect the functional area of responsibilities;
• Create, Review and maintain SOPs and documents that provide plans and guidance for control of procurement processes;
• Develops, documents, trains, and implements sustainable procurement processes across the company to adhere to internal financial controls utilizing change management practices;
• Establishes and maintains measurable performance metrics for all levels of procurement activities to include annual run rate and actual cost savings/cost avoidance, supplier performance, supplier quality, contract adherence, etc.
• Ensure a balanced workload across the team members.

Team Training and Development:

• Ensure all buyers perform their work in compliance with company policies and within the guidelines of Sequana Medical’s Quality System;
• Cultivate continuous growth and development of employees in within the Procurement team;
• Provide mentoring and coaching for team members;
• Set and review goals and objectives for team members;

Team Coordination and communication:

• Establish and maintain good relationships with all departments, especially production, QA, manufacturing, engineering and Logistics and Distribution;
• A strong communicator in both written and verbal forms to effectively work with customers, managers, and co-workers;
• Communicate progress and needs to department VP;
• Prepare and present data from various procurement processes and investigations;
• Act as procurement representative in project and program level meetings.

Key Requirements:

• Strategic thinking skills and ability to evaluate and propose solutions to improve;
• A self-starter and detail oriented, comfortable with ambiguity and change, with the ability to support multiple projects and business functions concurrently;
• Experience in the development of cost estimation and cost control, reporting, and record/document control is an additional plus;
• High level of business acumen and communication and presentation skills throughout varying levels of the organization;
• Demonstrated experience in negotiating prices and terms and conditions;
• Knowledge of market research, data analysis and purchasing best practices;
• A strong analytical mindset and attention to detail with outstanding organizational and follow-up skills;
• Relationship/team builder, both internally and externally with suppliers and employees;
• Exhibits a high degree of ethics and integrity with full transparency and builds trust;
• Resilient, self-motivated and able to work well under pressure;
• Cultivates and upholds a culture of interest and participation and demonstrates a collaborative approach to working with others;
• Proactively contributes to the team, optimistic and open to change;
• Manages time well, works independently, and prioritizes multiple tasks with a strong sense of urgency;
• Ensures cGMP concepts (Good Manufacturing Practices) are incorporated and respected;
• Medical device background and knowledge of relevant regulations (ISO 13485, FDA 21 CFR 820, etc.) quality systems and relevant concepts is an advantage;
• Proficiency in MS Office products, ERP systems, QMS systems and its underlying business processes;
• Proficient with Microsoft Excel, Outlook, PowerPoint, Word, and Power BI (preferred, not required);
• Fluent in verbal and written English and German.

Required Education / Experience:

• Master degree in a relevant business/commercial or manufacturing/engineering degree or equivalent education;
• 3+ years relevant experience in a procurement/supply chain role;
• Ideally has experience in a medical, pharma or food environment (ISO 13’485, FDA);
• Knowledge of ERP systems, QMS systems, Solid Works (CAD) is a plus.

If you are interested, please send your resume and motivation to careers@dev.sequanamedical.com

Apply now

The manufacturing engineer’s responsibilities include introduction of new products, designing of new processes, identifying areas for improvement, maintaining high levels of manufacturing and product quality as well as ensuring cost-efficiency and conformance with regulatory standards.
Furthermore, a Manufacturing Engineer is responsible for designing, implementing and reviewing the procedures and equipment involved in the manufacturing process. Their duties include researching automation techniques, testing new systems for efficiency and planning factory layouts to optimize production.
To be successful as a manufacturing engineer you should be able to work effectively within a team and have a high level of technical expertise.

Key Responsibilities:

• Lead or support internal projects.;
• Initiate and manage change management activities (CR/CO);
• Support the implementation of new products in our current production lines.;
• Support the definition of new process flows for existing or new products;
• Support the design transfer of products to internal production or suppliers;
• Lead or support CAPAs, NCMRs and Process deviations;
• Define and develop manufacturing processes, equipment, tools, fixtures, and methods;
• Create or support the creation of URS for new assets;
• Contribute to the elaboration of business cases;
• Define, create, review and update manufacturing documentation;
• Manage in ERP/MRP product and process information;
• Support validation activities like: validation assessments/validation plans, FAT&SAT protocols, IQ, OQ, PQ protocols and reports, CSV compliance analysis, test method validation, final inspection reports;
• Create, store and maintain information/documents in the QMS system;
• Interface with our suppliers, other Sequana sites and internal stakeholders on technical and organization issues;
• Actively seek opportunities for process improvement;
• Cultivates and upholds a culture of interest and participation and demonstrates a collaborative approach to working with others;
• Incorporates and respects cGMP concepts (Good Manufacturing Practices);
• Accountable to the execution on time and in the required quality of the requested activities;
• Maintain a structured and reliable activities scheduling (workload).

Key Requirements:

• Strong knowledge, interest and experience in electronics and mechanical manufacturing operations;
• Experience in medical implants manufacturing;
• Excellent problem solving and manufacturing process improvements skills (Six Sigma, Fishbone, 5-S, 5-Whys, 6M, …);
• Ability to think and act cross-functionally, interacting with various SMEs (Shop floor, QA, QC, engineering, etc.);
• Ability to effectively present information and support all stakeholders;
• Autonomous, structured, self-motivated, flexible, resilient with proactive and analytical thinking;
• Able to manage priorities in a fast and dynamic environment with a high emphasis on achieving results;
• Demonstrate excellent communication skills orally and written, ability to describe complex technical processes and qualifications and to translate it into clear, precise reports;
• Knowledge of automation technology is big plus;
• Excellent oral and written skills in German and English, fluency is an asset.

Required Education / Experience:

• 3+ years of experience as a Manufacturing or Process Engineer;
• Ideally with experience in medical, pharma or food environment (ISO 13’485, FDA);
• Knowledge of ERP systems, QMS systems, Solid Works (CAD) is a plus;
• Ideally demonstrated experience in application of Six Sigma and Lean Methods;
• Proficiency with personal computers, office applications and technical software.

If you are interested, please send your resume and motivation to careers@dev.sequanamedical.com

Apply now

Are you someone who loves to work in a fast paced, challenging environment where you will have the opportunity take on an impactful role in defining and driving purchasing initiatives? Do you thrive working in an environment where you can utilize your procurement skills to solve problems and build long-term solutions to advance procurement initiatives? Do you pride yourself on having an entrepreneurial spirit with the ability to see the big picture, deliver solutions and streamline processes? If you answered yes, we would love to discuss our Technical Buyer opportunity with you!
In this role, you will play an integral part in defining and modeling the future of procurement directly associated with Sequana Medical’s production.

Key Responsibilities:

• Ensure continuous supply of required goods and materials and communicate any supply problems which may pose a risk or impact on business operations;
• Ensure reliable performance for on-time, complete, and accurate delivery with the best value meeting requirements at the lowest cost;
• Stay current and up to date on any changes that may affect the supply and demand of needed products and materials and advise others of any impact;
• Support product change requests, review and communicate the impact on operational activity and capacity plans;
• Monitor and report on component obsolescence and develop plans for improving component obsolescence management;
• Support implementation and management of on-going operations for Procurement and eProcurement solutions;
• Support operations for the purchasing process primarily requisitioning and ordering;
• Process POs; ensure all necessary approvals are documented, the orders are placed, and shipments delivered on time;
• Work with the cross-departmental team(s) and suppliers to get feasibility studies and quotes on new items. Review and select best quotes from time, quality and pricing standpoint;
• Work collaboratively, negotiate and engage with stakeholders and suppliers regarding new projects, supplies, initiatives and advise on impact of change on purchasing and production activities;
• Contact suppliers to resolve price, quality, delivery or invoice issues.

Key Requirements:

• Proven purchasing experience and knowledge of relevant purchasing and sourcing concepts, preferably within the electronics manufacturing environment;
• Strong technical knowledge and understanding of electronics manufacturing processes;
• Project management experience;
• 3+ years’ experience in purchasing environment;
• Medical device background and knowledge of relevant regulations (ISO 13485, FDA 21 CFR 820, etc.) quality systems and relevant concepts is an advantage;
• Resilient, self-motivated and able to work well under pressure;
• Proficiency in MS Office products, ERP systems and its underlying business processes;
• Fluent in verbal and written English and German.

Required education and professional experience:

• Bachelor’s degree (B.A.) in a relevant business/commercial or manufacturing/engineering degree or equivalent education;
• Technical background and an apprenticeship in relevant field is an asset;
• Relationship/team builder, both internally and externally with suppliers and employees;
• Exhibits a high degree of ethics and integrity with full transparency and builds trust;
• Ability to coordinate several projects simultaneously;
• Analytical, numerically astute with strong proven problem identification and solution abilities;
• Attention to detail and accuracy;
• Engages interest and participation of others and has a collaborative approach to working with others;
• Proactively contributes to the team, optimistic and open to change;
• Computer literate, to include advanced Excel skills;
• Very quality oriented, organized and reliable.

If you are interested, please send your resume and motivation to careers@dev.sequanamedical.com

Apply now

Become part of a great team, which is responsible for the manufacturing of innovative, quality of life improving, high-tech medical devices. The Electronics and Mechanical Assembler responsibilities include soldering, assembling, cleaning, inspecting and testing electronic and mechanical components to ensure the highest quality of product.

Key Responsibilities:

• Mechanical assembly of the alfapump®, catheters and accessories to company specifications and procedures;
• Operate mechanical equipment including ultrasonic cleaning baths, ovens, vacuum chambers, tensile testing machines and table milling machines;
• Electronic assembly, including SMD soldering and gluing according to company specifications and procedures;
• Operate electrical test equipment including oscilloscopes, digital volt measures, function testers, custom test setups, inductive charging stations and Power Supplies;
• Testing of subassemblies and finished goods according to engineering specification and procedures;
• Packaging and labeling of finished goods to company specifications;
• Create manufacturing orders and track their progress in the ERP system;
• Receive goods to stock from manufacturing orders in the ERP system;
• Document non-conformities in the Quality Management System;
• Actively participate in continuous improvement initiatives providing recommendations and implementing enhancements to current methods and procedures, as needed;
• Assist in production/process audits, provide technical feedback and support Quality Assurance.

Key requirements:

• Must be able to follow both oral and written, demanding technical instructions in English;
• Ability to read engineering drawings and engineering schematics;
• Good eyesight, good coordination, motor skills, and dexterity;
• Demonstrate constant accuracy and thoroughness; actively seeks opportunities to improve quality, also for repetitive tasks;
• Able to work independently and in a team;
• Knowledge in MS Office Package;
• Experience in working with ERP systems is a plus.

Required Education / Experience:

• Completed apprenticeship in electronics or min. 2 years of relevant experience in manufacturing;
• Relevant practice in hand soldering of SMD components;
• Soldering certificate compliant to IPC-A-610 or similar is a plus;
• Relevant professional experience in the electronics and mechanical assembly of small high-tech devices;
• Experience working with a microscope;
• Experience in a highly regulated production environment, preferably in the MedTech industry, is a plus.

Working Conditions and Physical Requirements:

The majority of time is spent in clean room environment as well as in an ESD environment requiring the ability to use several machines, a computer, and telephone, which requires standing at extended lengths of time. Furthermore, the job duties often require working under a microscope. The work environment will have normal lighting and climate control tolerances. Additionally, the work setting will have moderate noise exposure, i.e. machine noise.

The working conditions and requirements indicated are representative of those that must be met by an employee to successfully perform the essential functions of the job.

Do you like the sound of this job and think you have what it takes? Then send us your CV today. We look forward to receiving your full application in English or in German in pdf format at careers@sequanamedical.com

Apply now

Creates and maintains the design history file owned by the Engineering department. Manages technical changes as part of our product’s life-cycle management in accordance with the company’s quality management system. Conducts product component verification. Manages R&D projects meeting timelines and budget. Supports other departments in technical matters. A motivated, self-organizing individual with strong analytical and communication skills.

Key Responsibilities:

• Creation and maintenance of the technical documentation on engineering matters throughout the life-cycle of product components of an implantable medical device system;
• Write product change requests in close collaboration with the regulatory and manufacturing team;
• Support the Regulatory Affairs and Quality team in technical matters;
• Product component verification activities;
• Technical performance analysis of products in the field;
• Failure root-cause analysis of returned products, non-conformities in production and devices under test;
• Management of internal and external resources within development projects.

Key requirements:

• Strong analytical skills;
• Ability to formulate complex technical content in an understandable way and according to regulatory guidance;
• Ability to work well independently and cross-functionally as part of an established team;
• Strong communication skills both verbally and in writing;
• Organized, reliable, attention to detail.

Required Education / Experience:

• MS or equivalent degree in biomedical, mechanical or electrical engineering;
• Minimum of 5 years R&D experience in industry, at least 3 years in the medical industry;
• Experience in medical device development according to regulatory requirements.

If you are interested, please send your resume and motivation to careers@sequanamedical.com

Apply now

Acts as subject matter expert for medical device software. Creates and maintains the design history file owned by the Engineering department. Manages changes of software as part of our production environment and our product’s life-cycle management. Conducts software verification and validation according to the guidance of the Regulatory Affairs department. Manages R&D projects meeting timelines and budget. Supports other departments in technical matters. A motivated, self-organizing individual with strong analytical and communication skills.

Key Responsibilities:

• Subject matter expert for medical device software;
• Writes change requests of software as part of our production environment and our product’s life-cycle management in close collaboration with the regulatory and manufacturing team;
• Creation and maintenance of the technical documentation on engineering matters throughout the life-cycle of product components of an active implantable medical device system in accordance with the company’s quality management system;
• Software verification and validation according to the guidance of the Regulatory Affairs department;
• Support the Regulatory and Quality Affairs team in technical matters;
• Technical performance and root-cause analysis of software used in product components or engineering and manufacturing test equipment;
• Software development according to IEC 62304 standard.

Key requirements:

• Proficient with software design, code development, code review and software release;
• Proficient with Integrated Development Environments and software release management;
• Experience with build servers and software test platforms;
• Strong analytical skills;
• Ability to formulate complex technical content in an understandable way and according to regulatory guidance;
• Ability to work well independently and cross-functionally as part of an established team;
• Strong communication skills both verbally and in writing;
• Organized, reliable, attention to detail;
• MS or equivalent degree in software engineering;
• Minimum of 5 years software development experience in a highly regulated industry;
• Minimum of 3 years experience in medical device software development;
• Experience in firmware development in C/C++ and application development in C#.

Required Education / Experience:

• MS or equivalent degree in software engineering;
• Minimum of 5 years software development experience in a highly regulated industry;
• Minimum of 3 years experience in medical device software development;
• Experience in firmware development in C/C++ and application development in C#.

We offer a full time (100%) contract in a very dynamic and international environment with an attractive salary package at our Zürich office.

If you are interested, please send your resume and motivation to careers@sequanamedical.com

Apply now

Organise and supervise an effective accounting of Sequana Medical NV and its subsidiaries

Key Responsibilities:

• Responsible for the accounting from A to Z
• Responsible for accurate and compliant accounting records
• Responsible for proper journal entries (manual, accrual, deferral, standard consolidation entries)
• Periodic balance sheet reconciliations
• Preparation of (M, Q, 6M, 12M) consolidated management accounts (IFRS)
• Preparation of statutory accounts (BEGAAP) and support the preparation of financial statements for the group (IFRS)
• Responsible for VAT, import, intrastat and any other required reporting to authorities in cooperation with the line manager
• Support in preparation of internal/external audits
• Working with consultants (eg proper filling of tax returns)
• Supervision and motivation of the (junior) accountant in the day-to-day transactional accounting
• Apply the internal controls in the accounting department (SOX)

Key requirements:

• Detailed knowledge of accounting and bookkeeping skills (IFRS and BE GAAP)
• Good level of Excel knowledge
• Reliable, accurate and in time working methods
• Enjoys working in an international team and being a team player
• Strong communication skills
• Structured and solution-oriented working attitudes
• Good English knowledge (verbal and writing) as it is our Company’s main language
• Protects organization’s value by keeping information confidential
• Eager to stay up to date with accounting trends and own development
• Experience with VAT reporting is an advantage

Required Education / Experience:

• Bachelor in accounting
• Minimum 3-5 year experience in accounting in an international setting

If you are interested, please send your resume and motivation to careers@dev.sequanamedical.com

Apply now

General Description

Under the Direction of the Chief Medical Officer, the Director of Clinical Operations will be leading the execution of our current and future clinical trials assigned to the director, which includes the management of the clinical department in collaboration with the other management functions in the clinical department.

Key Responsibilities

As a key member of the company’s management team, lead the company’s Clinical Department in collaboration with the other management positions in the clinical department and be responsible for the successful execution the company’s clinical trials and clinical trial strategy assigned to the clinical director. Design new clinical studies and manage their execution, including the execution of ongoing studies, up to completion, including finalization of clinical study report and publication. You will work with the Company’s established research partners and you will help establish new research partners.

Principal duties associated with these responsibilities are summarized as follows:

1. Provide leadership and management direction to the clinical and safety team members for the assigned programs, this includes oversight for the following activities listed, but not limited to:
   • Protocol development and implementation, CFR Design, project planning and report writing
   • Assistance with site selection and investigator recruitment
   • Assisting sites with EC applications
   • Site initiation and staff training (including CRO training)
   • Monitoring of clinical data
   • Study device inventory and reporting
   • Adverse event monitoring and reporting
2. Represent, together with other clinical management team members, the clinical team and ensure clinical requirements are aligned with other internal departments (such as, but not limited to R&D, Regulatory and Quality, Human Resources)
3. For the assigned projects ensures the clinical requirements for regulatory filings are met (Notified Bodies, including Post Market Clinical Follow up, FDA, and other where applicable)
4. Collaborate with In- and external partners (including investigators) to drive study results presentation and/or publication.
5. Set and maintain assigned clinical operations budget for assigned programs
6. Oversee- for assigned programs – clinical study execution to ensure studies are completed on time, within budget, and in compliance with Pahram and Device SOPs, ICH/GCP guidelines, and applicable regulations
7. Mentor and develop clinical team members to foster individual growth and promote internal talent
8. Develop training plans and programs to enhance clinical operations
9. Assist in resource planning and budgeting to meet deliverables and achieve company goals
10. Build effective working relationships with both internal and external partners
11. Set strategy direction for clinical outsourcing, oversight; provide leadership in CRO and vendor selection and management; establish and maintain strong relationships with CROs
12. Measure and evaluate performance and take appropriate action if applicable
13. Represent company at professional meetings, congresses and other industry events
14. Participate in the development and review of standard operating procedures
15. Understanding and application of the quality Systems within the company and in compliance with international standards
16. Remains up to date with the relevant medical literature pertaining to the assigned therapeutic domain(s)
17. Travel as required including intercontinental travel

Key requirements

• Demonstrated capacity to lead a clinical team, including remote employ
• Ability to develop and maintain professional relationships with hospitals, doctors and clinical staff
• Strong interpersonal and communication skills, including the ability to present results at major scientific meetings
• Expert knowledge of how to conduct a GCP study and experience with regulatory requirement for Pharma and/or Medical Device clinical studies (including IND/IDE,PMA,CE mark/MDR)
• Good organizational and project management skills and ability to handle multiple diverse projects simultaneously
• Experience developing and executing a scientific publication strategy, as well as organizing small scientific meetings (such as expert meetings or advisory boards)
• Ability to conduct interviews with physicians to gain feedback on products
• Expert proficiency in reading, writing and speaking English
• Ability and appetite to work in a fast paced start up environment
• Desire to help develop strategy marketing plans
• Interest in working with R&D to ensure that new products exceed customer expectations
• Position may require up to 50% travel

Required Education / Experience

• Post graduate Degree in Life Sciences or appropriate experience
• 7+ years of Pharma and/or Medical Device Clinical Trial Management (ideally experienced within Active Implantable Devices and/or Pharmacautical Infusion Products an international context) Proficient in reading, writing and speaking English (multiple languages a plus)
• Knowledge of and expertise in (ideally including a KOL network) the following therapeutic domains are considered a strong advantage: heart failure and/or chronic liver disease

If you are interested, please send your resume and motivation to careers@dev.sequanamedical.com

Apply now