Group Manager Regulatory Affairs 100% — Medartis

Full description

We are looking for a Group Manager, the one responsible for our global regulatory strategy, a team that ensures compliance with all requirements and drives efficient processes in a dynamic, international environment.

Group Managers: Regulatory Affairs 100%

Your remit

• Professional and disciplinary leadership and further development of a legal action team
• Ensure compliance with regulatory requirements for the development, manufacture and market introduction of medical devices
• Planning, coordination and management of regulatory activities and projects
• Technical support and advice of the team and internal stakeholders (R&D, quality, production) in regulatory issues
• Responsibility for planning, implementing and monitoring national and international licensing procedures (especially CE marking, FDA)
• Ensure the quality, consistency and completeness of technical documentation
• Implementation and monitoring of CE conformity assessment procedures
• Management and review of product files (DHF/DHR) and execution of Design Reviews
• Evaluation of product changes in terms of regulatory requirements and reporting requirements
• Central contact person for authorities, notified bodies and external partners
• Cooperation in audits and inspections, as well as ensuring successful preparation and implementation
• Further development, harmonisation and implementation of regulatory processes, templates and tools
• Guidance and support in defining and implementing regulatory strategies

Your qualifications

• Completed studies in Life Sciences, Engineering, Pharmacy or Similar
• Multi-year experience in the field of legal action in the medical technology or pharmaceutical industry
• Management experience and proven experience in the professional management of projects/teams
• A well-founded knowledge of relevant regulatory requirements
• Experience in technical documentation and in approval processes
• Very good German and English knowledge in word and writing
• Safe handling of MS Office as well as experience with PLM or document management systems
• Extensive organisational skills and a high level of quality awareness
• Strength of communication and joy in working with different stakeholders
• Structured, solution-oriented and self-responsible working methods

About Medartis

Medartis is one of the leading manufacturers of osteosynthesis products in the area of facial skull and extremities. Medartis has committed itself to providing surgeons and surgical staff with the most innovative titanium implants and instruments and offering the best service for the benefit of the patient.

We offer you a responsible and varied activity with high quality requirements in a growing international company with advanced social benefits.

We look forward to receiving your complete online application. Medartis

Human Resources

T +41 61 633 34 34

www.medartis.com