
Medical Device Regulatory Affairs Specialist
1 day ago
Company Overview:
Bondi Chefrekrytering AB is a leading Swedish medtech company with high potential, committed to innovation and excellence.
Job Summary:
We are seeking a highly skilled Senior RA Specialist Med Tech to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with laws and regulations set by Healthcare products' Regulatory Agencies.
Detailed Job Description:
- Develop and implement regulatory strategies for medical devices, including product development, market placement, and commercial supply.
- Act as the primary point of contact for regulatory affairs activities, including meetings with license partners and responding to queries from regulatory agencies.
- Perform regulatory review and approval of product labeling and marketing materials for new products and licensing activities.
- Maintain technical files and regulatory strategies for medical devices, ensuring compliance with EU and US regulations.
Key Responsibilities:
- Responsible for maintaining technical files and regulatory strategy for medical devices for license partners.
- Develop, create, submit, and maintain product registrations for the company's products during new product development and line extensions for licensing activities.
- Surveillance of new and changed regulatory requirements and guidance in key market areas such as the EU and US, and communicate such changes externally to our license partners when requested.
Reporting Structure:
This role reports directly to the Global Head of Quality & Regulatory Affairs.
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