Quality Assurance Regulatory Affairs Manager

vor 4 Wochen

Munich, Bayern, Deutschland Barrington James Vollzeit
Barrington James QARA Division Seeks Quality Assurance & Regulatory Affairs Manager

Barrington James QARA division is seeking a proactive and experienced Quality Assurance & Regulatory Affairs (QA/RA) Manager to play a pivotal role in maintaining and improving our Quality Management System (QMS) and securing global market access through compliance with international regulations.

This is a 4-day on-site, 1-day remote opportunity that requires a strong background in the medical device industry, with a focus on QMS knowledge and fluency in English.

To be considered for this role, you should have:

  • At least 4 years of experience in the medical device industry in QA/RA
  • QMS knowledge and fluency in English
  • Desirable: MDD - MDR exposure and hands-on experience with technical file writing

Responsibilities:

Key Responsibilities
  • Lead and manage all quality assurance activities, including maintaining ISO 13485 compliance
  • Oversee the regulatory strategy for existing and new products, including EU MDR and FDA submissions
  • Ensure continuous improvement of our QMS, handling internal and external audits
  • Manage technical documentation, risk management, and CAPA processes
  • Act as a point of contact with regulatory bodies and certification organizations
  • Coordinate the preparation and submission of regulatory filings (CE Marking, 510(k), etc.)
  • Participate in the transition of paper to electronic Quality Management System

If you are interested in this role, please apply or email us for more information.

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