Group Manager Regulatory Affairs 100% — Medartis

Role overview

We are looking for a Group Manager Regulatory Affairs who is responsible for our global regulatory strategy, leads a team, ensures compliance with all requirements and drives efficient processes in a dynamic, international environment. Group Manager Regulatory Affairs 100% Your area of responsibility Professional and disciplinary management as well as further development of a Regulatory Affairs team Ensuring compliance with regulatory requirements for the development, manufacture and market launch of medical devices Planning, coordination and control of regulatory activities and projects Professional support and advice to the team and internal stakeholders (R&D, quality, production) in regulatory issues Responsibility for the planning, implementation and monitoring of national and international approval procedures (in particular CE marking, FDA) Ensuring the quality, consistency and completeness of technical documentation Conducting and monitoring CE conformity assessment procedures Management and review of product files (DHF/DHR) as well as conducting design reviews Evaluation of product changes with regard to regulatory requirements and reporting obligations Central contact person for authorities, notified bodies and external partners Participating in audits and inspections as well as ensuring successful preparation and implementation Further development, harmonization and implementation

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