Public summary
A Berlin-based medical technology company is seeking a Regulatory Affairs & Quality Assurance Manager to lead the certification of an innovative MRI medical device in the US and Europe and manage its Quality Management System. The role involves driving CE and FDA submissions, authoring regulatory documentation, ensuring compliance and risk management, managing product testing, and liaising with notified bodies and authorities. The position offers up to €130,000 per year, an international English-speaking environment, flexible working, and career development opportunities.
Location and work setup
- Location
- Berlin
- Remote status
- On-site
- German requirement signal
- No German Required Detected
- Detected job language
- English
Salary
EUR 80000.00 - 130000.00 YEAR
Responsibilities
Lead CE Class IIa medical device certification and FDA 510(k) submission processes; author, review, and maintain regulatory technical documentation; manage risk activities under ISO 14971; coordinate product testing for safety and compliance; define and improve QMS processes aligned with ISO 13485 and FDA regulations; conduct gap analyses and implement corrective actions; collaborate with engineering on design reviews and testing; act as primary contact for notified bodies and authorities; support post-market surveillance, vigilance, and complaint handling with proper regulatory reporting.
Qualifications
Degree in Life Sciences, Engineering, or related field; minimum 7 years regulatory experience in medical devices; proven track record with Class II device CE and/or FDA 510(k) certification; deep knowledge of ISO 13485 and experience managing product testing for electromagnetic safety, cybersecurity, and biocompatibility; experience liaising with notified bodies and regulatory authorities; strong communication skills in English. Preferred qualifications include auditor accreditation, risk management training (ISO 14971), clinical evaluation experience, and interest in MRI technology.