
Medical Device Regulatory Lead
8 hours ago
Are you passionate about regulatory affairs? Do you want to work in a dynamic global organization and collaborate with expert professionals?
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at TN Norway.
About the Role:
The successful candidate will be responsible for planning, managing, and tracking regulatory CMC submissions and regulatory documentation. This includes Drug Master Files for raw, ancillary, and starting materials used in the manufacturing of cell and gene therapies.
Your Key Responsibilities:
- Support activities at Thermo Fisher Scientific site(s) located in Norway for the bead-based technology products and processes (part time).
- Serve as the liaison between Research scientists and key cross-functional partners, including Regulatory Affairs, Quality Control, Manufacturing Sciences, Product Management, and IP Legal.
- Collect, consolidate, and ensure accuracy of documentation required for regulatory support in target markets (EU, US, and other global markets).
- Create and maintain up-to-date product technical documentation - Master Files.
- Review and approve product labeling and marketing information to assure compliance with applicable requirements.
- Provide regulatory support and expertise to new product introduction project teams and different departments.
- Participate in change control activities by evaluating the impact of manufacturing changes on technical documentation and submitting updates to competent authorities.
- Develop regulatory affairs internal policies and procedures and provide training as required.
- Appropriately handle confidential information.
What We Offer:
TN Norway is a rapidly growing international company with an encouraging working culture and outstanding development possibilities to increase your potential.
As a member of our team, you will have the opportunity to work in a dynamic global organization and collaborate with expert professionals.
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