Regulatory Affairs Manager

Salary/Rate:60,000EUR - 70,000EUR
Job type:Perm
Business Sectors:Regulatory Affairs, Quality
Job ref:25105
Post Date:17. 04. 2024

About the Role

Regulatory Affairs Officer
Are you looking for a new challenge in regulatory affairs?

I am currently supporting a client who specializes in sleep diagnostics in southern Germany in hiring an expert in EU MDR, approval processes, IEC 60601, IEC 62304 and ISO 14971.

This is a hybrid working position where you can work 2/3 days from home.

  • Implementation and maintenance of regulatory approval of medical devices in accordance with EU MDR
  • Assisting in the compilation of documentation and supporting in the creation and maintenance of risk management files in accordance with ISO 14971 and usability files in accordance with IEC 62366-1
  • Support international distributors in the approval process of the medical devices
  • PMS activities such as PMS files and vigilance investigations

Your profile
  • Experience in areas such as regulatory affairs or technical documentation in the MedTech or medical device industry
  • Solid foundational knowledge of relevant regulatory and normative requirements (MDD, MDR, ISO 13485 etc.)
  • IT Skills such as MS Office
  • Good communication and organizational skills as well as independence and reliability
  • Fluency in English and German

Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management.
+49 30 1663 7750