Country Regulatory Compliance Specialist

2 weeks ago


Oslo, Oslo County, Norway Thermo Fisher Scientific Full time
Regulatory Compliance Role

As a Country Regulatory Compliance Specialist at Thermo Fisher Scientific, you will play a critical role in preparing, reviewing, and coordinating regulatory submissions with the Norwegian Medical Products Agency (RA) and Ethics Committee (EC). Your expertise will ensure that all submissions align with our global submission strategy.

Responsibilities:
  • Coordinate regulatory submissions and communicate with internal clients regarding local regulatory strategies
  • Develop and maintain knowledge of company SOPs, client SOPs, and current regulatory guidelines
  • Prepare regulatory compliance review packages and country-specific Patient Information Sheet/Informed Consent form documents
  • Coordinate with internal functional departments to ensure site tasks are aligned with submissions activities

Requirements:
  • 1+ year of related experience or equivalent combination of education and experience
  • Excellent communication skills and attention to detail
  • Proficiency in English and Norwegian
  • Ability to work independently and as part of a team

About Thermo Fisher Scientific:

Our mission is to empower our customers to make the world a healthier, cleaner, and safer place. We value diverse experiences, backgrounds, and viewpoints. At Thermo Fisher Scientific, we expedite research and provide support to patients in need. We are part of a global community that shares our values of Integrity, Intensity, Innovation, and Involvement.


We look forward to reviewing your application.



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