5+ years eu/fda medical device regulations experience
Iso13485 mdr mdsap certification knowledge
Class iia iib and 510k registration experience
Roche is seeking a Regulatory Affairs Manager Freelancer in Vienna, Austria, with expertise in Medical Device regulations to ensure compliance for their innovative healthcare products. The ideal candidate will have a strong background in regulatory processes, experience with class IIa and IIb medical devices, and a passion for working in dynamic, cross-functional teams
Job Summary
The role supports product development activities to ensure regulatory compliance for mySugr products.
Candidates must be pragmatic individuals eager to expand into new fields of products and services in a fast-paced environment.
The company offers an innovative agile working environment with opportunities for professional development and growth.
Matching Summary
Match Score: 85
Roche is seeking a Regulatory Affairs Manager Freelancer in Vienna, Austria, with expertise in Medical Device regulations to ensure compliance for their innovative healthcare products. The ideal candidate will have a strong background in regulatory processes, experience with class IIa and IIb medical devices, and a passion for working in dynamic, cross-functional teams.
Skills & Requirements
Must-have
5+ years EU/FDA Medical Device regulations experience
ISO13485 MDR MDSAP certification knowledge
Class IIa IIb and 510k registration experience
Audit experience with Authorities and notified bodies
Process optimization for multiple jurisdictions
Nice-to-have
Diabetes industry knowledge
Agile environment experience
Love for innovative apps or software development
Cross-functional collaboration skills
Key Requirements
More than 5 years professional experience
Experience with ISO standards for Quality Management
Experience with Risk Management and Software development
Excellent written and verbal communication skills in English