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Medical Device Regulatory Affairs Specialist
3 hours ago
This is an excellent opportunity to become part of a global medtech company with high growth potential.
Purpose:
- Develop and execute regulatory strategies for medical devices throughout their life cycle, from product development to commercial supply and maintenance.
- Act as the primary point of contact for regulatory affairs with license partners, ensuring compliance with laws and regulations set by healthcare regulatory agencies.
Key Responsibilities:
- Main contact for RA activities, participating in regular meetings with license partners to discuss regulatory requirements and best practices.
- Lead the development, creation, submission, and maintenance of product registrations for new products and licensing activities, aligning with regulatory agency requirements.
- Conduct thorough reviews and approvals of product labeling and marketing materials to ensure regulatory compliance.
- Prepare and submit changes or requested documentation to regulatory agencies and respond to queries and requests in a timely manner.
- Maintain awareness of new and changing regulatory requirements in key markets, such as the EU and US, and communicate updates to license partners when necessary.
- Responsible for maintaining technical files and regulatory strategies for medical devices on behalf of license partners.
The role reports directly to the Global Head of Quality & Regulatory Affairs.
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