Start your career at VYGON and contribute to a meaningful mission: Value Life.

We develop, manufacture, and distribute high-tech medical devices, ensuring the traceability of our products from development to distribution through rigorous quality controls. Our group currently comprises 26 subsidiaries and 11 production facilities, 8 of which are located in Europe.

Working at VYGON means being part of an international group, but also an independent family business. Thanks to the work of our 2,619 employees, Vygon manufactures approximately 210 million medical devices every year.

At VYGON, integrity, commitment, open-mindedness, the pursuit of improvement and respect for people are at the heart of our actions.

We are committed to a diverse and inclusive working environment and our recruitment process is designed to provide equal opportunities for all applicants.

• Preparation, creation and maintenance of technical documentation for national and international product approvals, with a focus on Europe and the USA.
• Compilation of technical documentation for international product registrations by the parent company
• Planning and execution of PMCF activities
• Preparation and updating of plans and reports in accordance with MDR (e.g. SSCP reports, PMCF reports, PSUR)
• Close professional collaboration with product development
• Maintenance and support of the EUDAMED database
• Communication with the registration offices and authorities
• Preparation of data for the creation of biological and clinical assessments
• Monitoring of legal and regulatory requirements
• Creation and maintenance of documents for the quality management system according to ISO 13485 and MDR
• Communication with VYGON branches
• Support and guidance during audits and inspections
• Completed technical or scientific studies, preferably in biomedical engineering, microbiology, process engineering or similar.
• Several years of professional experience in the approval of medical devices and the creation of technical documentation
• Sound knowledge of the legal requirements for medical devices (e.g. Regulation (EU) 2017/745 MDR, EC and FDA directives)
• Analytical, process- and solution-oriented thinking and action, combined with very good technical understanding
• A structured, conscientious and team-oriented work style and convincing communication skills.
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