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Senior Regulatory Specialist
8 hours ago
This is an excellent opportunity to work with an innovative Swedish medtech company that has high growth potential.
The purpose of this role is:
- To be responsible for regulatory strategy and provide guidance on regulatory affairs matters throughout the life cycle of medical devices.
- To act as a Regulatory Affairs Expert with new and existing license partners and ensure compliance with relevant laws and regulations.
Main tasks and responsibilities:
- Be the main contact for regulatory affairs 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.
- Review and approve product labeling and marketing material for new products and licensing activities.
- Create and submit changes or requested documentation to regulatory agencies and respond to queries and requests from those upon assignments.
- Monitor new and changed regulatory requirements and guidelines in key markets, and communicate these changes to license partners when required.
- Maintain technical files and regulatory strategies for medical devices for license partners.
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