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Global MedTech Regulatory Strategy Expert
6 hours ago
This is a unique chance to be part of a rapidly evolving medtech industry and contribute to the success of a pioneering Swedish company.
Key Functions:
- Design and execute comprehensive regulatory strategies for medical devices throughout their lifecycle, from product development to ongoing commercial supply and maintenance.
- Act as the main point of contact for regulatory affairs with license partners, ensuring strict adherence to laws and regulations set by healthcare regulatory agencies.
Main Responsibilities:
- Be responsible for RA activities, including regular meetings with license partners to discuss regulatory requirements and best practices.
- Oversee the development, creation, submission, and maintenance of product registrations for new products and licensing activities, aligning with regulatory agency expectations.
- 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.
- Stay informed about new and changing regulatory requirements in key markets, such as the EU and US, and communicate updates to license partners when necessary.
- Ensure the maintenance of accurate technical files and regulatory strategies for medical devices on behalf of license partners.
This position reports directly to the Global Head of Quality & Regulatory Affairs.
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