Senior Regulatory Affairs Manager (m / f / d) Medical Devices
As a Senior Regulatory Affairs Manager (m/f/d) you'll take ownership of all Regulatory topics in a very critical role to the company's future and help to fulfil relevant national and international regulatory requirements. A great opportunity to join a leading Medical Device company in Germany with a great portfolio of products .
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Your Responsibilities Will Include, But Are Not Limited To:
Coordination and implementation of the approval of our products for international markets
Creation of regulatory strategies and plans for worldwide approvals
Independent preparation of the submission documentation for the global approval of medical devices
Creation of all required registration documents and procurement of the necessary certifications in exchange with external interfaces
Preparation, organisation and support of audits by notified bodies and authorities
Contact person (m / f / d) for regulatory issues
continuously drive the optimisation of global, cross-location regulatory affairs processes
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Key Requirements:
Bachelor of Science degree in engineering or a scientific/technical discipline
A minimum of 7 years related experience in the medical device industry, with at least 5 years of experience in Regulatory Affairs
Knowledge of the normative and regulatory requirements for medical devices (ISO 13485: 2016, ISO 14971: 2019, Directive 93/42 / EEC and Regulation (EU) 2017/745 (MDR)
Support with international registrations
Demonstrated ability to work constructively across all functions of the organisation
Very good written and spoken German and English
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If you are interested in the role, apply online today.
