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Senior RA Specialist Med Tech Position
10 hours ago
This is a fantastic opportunity to join a forward-thinking international medtech company that offers exciting prospects for professional growth.
Main Objectives:
- Drive regulatory affairs strategies for medical devices through all stages of their lifecycle.
- Work closely with license partners to handle regulatory matters effectively, ensuring conformity with laws and regulations imposed by healthcare regulatory authorities.
Main Tasks:
- Be the key contact for RA activities, participating in frequent meetings with license partners to share knowledge and provide insights on regulatory requirements.
- Oversee the development, submission, and maintenance of product registrations for new products and licensing activities, guaranteeing alignment with regulatory agency standards.
- Review and approve product labeling and marketing materials meticulously to ensure they comply with regulatory guidelines.
- Organize the preparation and submission of changes or requested documentation to regulatory agencies and respond promptly to queries and requests.
- Keep up-to-date with new and evolving regulatory requirements in key markets like the EU and US, communicating updates to license partners as necessary.
- Ensure the maintenance of accurate technical files and regulatory strategies for medical devices on behalf of license partners.
This role reports to the Global Head of Quality & Regulatory Affairs.
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