Positionsnummer / Reference Number


Position / Job Title

Manager Regulatory Affairs

Aufgaben / Tasks

• Formulation of regulatory strategies as well as preparation and compilation of technical documentation for various countries/regions with a current focus on the EU

• Lively cooperation with different internal stakeholders (Manufacturing, R&D and Quality) with the aim to successfully register new products as well as evaluate the impact of changes to already existing products

• Supporting the preparation and conduction of audits carried out by multiple notified bodies and contribute to setting up and maintaining a regulatory intelligence system

• Direct communication with authorities, affiliates and partners located around the globe

Qualifikationen / Qualifications

• Scientific university degree paired with multiple years of experience working in Regulatory Affairs within the medical device industry

• Good intercultural communication skills in combination with significant regulatory knowledge within the Europe, (South) America and/or other relevant regions

• Detail oriented way of working as well as flawless English skills in both verbal and written form (especially German and any other language is an advantage)

Weitere Informationen / Further Information

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