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Regulatory Affairs Specialist III

2 weeks ago

Oslo, Oslo County, Norway TN Norway Full time

We are seeking a Regulatory Affairs (RA) Specialist to join the Biosciences Division Regulatory Affairs Team.

Key responsibilities:

  • Support activities at Thermo Fisher Scientific site(s) located in Norway for bead-based technology products and processes.
  • Liaise between Research scientists and cross-functional partners, including Regulatory Affairs, Quality Control, Manufacturing Sciences, Product Management, and IP Legal.
  • Collect and consolidate 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 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.