Regulatory Affairs Manager
Salary/Rate:€60,000 - €75,000 DOE
Job type:Perm
Town/City:Stuttgart
Country:Germany
Business Sectors:Regulatory Affairs
Job ref:25461
Post Date:27. 09. 2024
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About the Role
Would you like to drive international approvals for a market-leading medical device company?
Are you interested in working with innovative biomaterial products?
We're searching for a Regulatory Affairs Manager for our client in the Stuttgart area!
Key Responsibilities:
Requirements:
If you're interested in this position, please apply and/or contact Hollie Dear at Adaptive Life Science for more information.
Are you interested in working with innovative biomaterial products?
We're searching for a Regulatory Affairs Manager for our client in the Stuttgart area!
Key Responsibilities:
- Developing and maintaining technical documentation
- Managing international regulatory approvals, particularly in the USA, including strategy, coordination, preparation, and submission.
- Assisting distributors with regulatory matters
- Handling communication with regulatory authorities
- Conducting Post-Market Surveillance through database research, trend analysis, evaluation, and reporting
- Investigating and reporting incidents and Field Safety Corrective Actions (FSCAs).
- Overseeing change management and process improvements
Requirements:
- A degree in Biomedical Engineering, Medical Technology, or a related field
- Good experience in the regulated medical device industry (ISO 13485, ISO 14971, MDD, MDR, QSR, MDSAP)
- Expertise in obtaining medical device approvals, particularly for the US FDA market.
- You enjoy handling cross-functional department communication and advising on regulatory affairs topics
- Fluency in German and English
If you're interested in this position, please apply and/or contact Hollie Dear at Adaptive Life Science for more information.