Senior RA Specialist Med Tech
5 days ago
This is an excellent opportunity to join an innovative and international Swedish medtech company with high potential at an exciting time in its evolution.
Purpose of position:
- Responsible for regulatory strategy, guidance to the organization on regulatory affairs matters throughout the life cycle of a medical device from product development, placing product on the market, and ongoing commercial supply and product maintenance for the company's new and existing license partners.
- Acting as the Regulatory Affairs Expert with new and existing license partners and ensuring compliance with laws and regulations set by the Healthcare products' Regulatory Agencies.
Detailed activities and responsibilities:
- Be the main contact for RA activities, including participating in regular meetings with license partners.
- Develop, create, submit, and maintain product registrations for the company's products during new product development and line extensions for licensing activities.
- Perform regulatory affairs review and approval of product labeling and marketing material for new products and licensing activities.
- Create and submit changes or any other requested activities/documentation to regulatory agencies and respond to queries and requests from those upon assignments.
- 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.
- Responsible for maintaining technical files and the regulatory strategy for medical devices for license partners upon assignments.
Report to Global Head of Quality & Regulatory Affairs.
If you are interested, please contact Niklas Claesson.
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