Regulatory Affairs Director
hace 1 semana
Cpl Healthcare is seeking an experienced Regulatory Affairs Director to lead our medical device lifecycle management efforts. This is a full-time, permanent position based in Madrid, Spain.
About the RoleIn this role, you will be responsible for strategic lifecycle management of our medical devices post-CE approval and operational execution management with our regulatory service provider. Your primary focus will be on ensuring compliance with regulatory requirements and providing guidance to internal teams.
Main Responsibilities- Lead and support all post-market surveillance activities for our medical device portfolio in the UK, Europe, and growth regions.
- Drive all regulatory affairs strategies for global regions.
- Oversight and advice to the regulatory service provider on medical device maintenance and submission strategies.
- Prepare high-quality documentation for labeling regulatory submissions.
- Represent the Regulatory Affairs Lifecycle Management – Medical Devices team internally and externally.
To succeed in this role, you will need:
- At least 8 years of experience in Regulatory Affairs within the medical device sector.
- A sound understanding of new registrations and post-market surveillance activities.
- Confident management of medical devices in global regions.
We offer a competitive salary of €80,000 - €100,000 per annum, depending on experience. You will also receive a comprehensive benefits package, including health insurance, retirement plan, and professional development opportunities.
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