Flexible options available (full-time and part-time/job sharing).
Ivdr compliance expertise
Fda submission preparation
Mdsap registration experience
Roche is seeking a Regulatory Affairs Manager for its subsidiary TIB Molbiol in Berlin, responsible for ensuring compliance and facilitating the global market introduction of in-vitro diagnostics. The ideal candidate should have a strong background in regulatory affairs, particularly with FDA submissions and international regulations, along with excellent communication skills in both German and English
Job Summary
This role serves as a pivotal point for global market launch strategies of In-vitro diagnostics at TIB Molbiol, a Roche subsidiary.
The successful candidate will ensure technical documentation compliance with IVDR and manage regulatory submissions for the US FDA and MDSAP regions.
Roche fosters a culture of personal expression and genuine connections where every voice matters to advance science and healthcare globally.
Matching Summary
Match Score: 85
Roche is seeking a Regulatory Affairs Manager for its subsidiary TIB Molbiol in Berlin, responsible for ensuring compliance and facilitating the global market introduction of in-vitro diagnostics. The ideal candidate should have a strong background in regulatory affairs, particularly with FDA submissions and international regulations, along with excellent communication skills in both German and English.
Skills & Requirements
Must-have
IVDR compliance expertise
FDA submission preparation
MDSAP registration experience
Change control evaluation
Post-market surveillance activities
Nice-to-have
Active participation in MDSAP audits
Strategic counseling for R&D teams
SOP creation for FDA regulations
Strong communication skills
Self-directed problem solving
Key Requirements
Bachelor's degree in Biology, Chemistry, or related field
Minimum 3 years Regulatory Affairs experience in IVD
Proven experience with FDA 510(k), PMA, or De-Novo processes