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About the Role
As a Senior Regulatory Affairs Manager, you will shape the global approval strategy for innovative in-vitro diagnostics (IVD) and contribute to making life-saving technologies available internationally. You will act as a central interface between local organization, international markets, and global regulatory functions, driving complex approval projects in a collaborative team environment.
Responsibilities
- Lead international registrations, including preparation, submission, and management of IVD product approvals with a focus on the USA (FDA: 510(k), PMA, De-Novo, Q-Submissions) and MDSAP markets.
- Provide strategic R&D consultation and develop/release SOPs according to FDA 21 CFR Part 820 (Design Control, Risk Management).
- Develop innovative solutions and guide interdisciplinary teams through complex regulatory challenges.
- Create and maintain parts of the Technical Documentation according to IVDR, conduct regulatory assessments for product changes, and maintain existing approvals.
- Represent strategic interests in critical authority inquiries, coordinate responses, and participate in Notified Body audits, FDA inspections, and MDSAP audits.
Requirements
- Proactive personality comfortable in a dynamic matrix organization and navigating complex stakeholder landscapes.
- Completed science degree (Master or B.Sc. with extensive senior practical experience in Biology, Chemistry, Pharmacy, Medical Technology, or Regulatory Affairs).
- Extensive (7+ years) in-depth expertise and strategic experience in Regulatory Affairs for In-vitro Diagnostics (IVD) or Medical Devices.
- Proven practical experience and professional responsibility for FDA submissions (e.g., 510(k), PMA, De-Novo, Q-Submissions) and thorough knowledge of US market requirements.
- Strong knowledge of FDA 21 CFR Title 21, IVDR, ISO 13485, and the MDSAP framework, including practical experience in Change Control and audits.
- Excellent negotiation and communication skills (including at management level), leadership competence, analytical sharpness, solution-oriented approach, and fluent German and English (C1 level).
Skills
- Regulatory Affairs
- In-vitro Diagnostics (IVD)
- Medical Devices
- FDA Submissions (510(k), PMA, De-Novo, Q-Submissions)
- MDSAP
- IVDR
- ISO 13485
- Change Control
- Audits
- Risk Management
- Design Control
- Technical Documentation
- Communication
- Negotiation
- Leadership
Location
- Berlin
- On-site (minimum 3 days per week)
Work Type
- On-site
- Full-time
Experience Level
- Senior (7+ years)
Education Level
- Master's degree or B.Sc. in a science field
About the Company
- A healthier future drives us to innovate.
- Over 100,000 employees globally are dedicated to advancing science and ensuring access to healthcare.
- Our efforts result in over 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products.
- We empower each other to explore new possibilities, foster creativity, and keep ambitions high to deliver life-changing healthcare solutions with global impact.
Equal Opportunity
- Roche is an Equal Opportunity Employer.