Regulatory Analyst full time
Thermo Fisher Scientific, Inc.
Lelystad, Netherlands
6 dagen geleden

How will you make an impact?

The Associate Regulatory Analyst will be responsible for working closely with the Quality System team and the Regulatory Affairs team at the Lelystad manufacturing site to provide regulatory guidance for new product introductions, product transfers, post-

market surveillance and compliance activities, within the regulatory framework applicable to veterinary in vitro diagnostics.

Key objectives of the role :

  • Writes, coordinates, compiles, and submits Regulatory documents to the Regulatory Agencies, in compliance with the (national) regulatory regulations and requirements as applicable for veterinary in vivo diagnostics.
  • Determines the scope of information / documentation necessary for new registration applications and determines post-approval changes to regulatory agencies.
  • Performs review and approval of documents such as SOPs, WINs, and Specifications (raw material and finished product) for regulatory compliance.
  • Services as RA subject matter expert for the site and keeps current in regard to the applicable regulations, competitors regulatory activities.
  • Ensures regulatory project deadline and performance standards are established and met.
  • Reviews and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
  • Support post-market surveillance and vigilance activities, and any product recall.
  • Participate in external regulatory inspections and ISO audits.
  • Participate in customer audits / technical meetings where applicable.
  • Maybe required to perform other related duties as required and / or assigned.
  • Requirements :

  • Minimum requirement is a bachelor’s degree in biology, life sciences, or related discipline.
  • Minimum of 3 years professional experience in Regulatory Affairs relating to pharmaceutical, biologics or medical devices.
  • Must have excellent interpersonal skills and the ability to communicate processes, timelines and schedules clearly.
  • Excellent problem solving and planning skills required
  • Direct and positive experience in communicating with Regulatory Authorities and Distributors.
  • Must be familiar with relevant regulations; formal training and / or advanced courses is preferred.
  • Languages : Fluent English, local language is a plus
  • At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission enabling our customers to make the world healthier, cleaner and safer.

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