Job Summary
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 90,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
The Genetic Sciences Division of Thermo Fisher Scientific is seeking a Regulatory Specialist to join the exciting area of in vitro diagnostics. This position will provide tactical support to the Warrington site team and where required the In-Vitro Diagnostic core teams. The role will be part of the Global Regulatory Affairs department and will be located at the Warrington site in the UK
The incumbent will perform regulatory activities including carrying out regulatory assessment of customer complaints for reportability, regulatory assessment of on market product changes, supporting regulatory filings and registrations by gathering supporting documents and reviewing labelling, advertising and promotional materials on IVD and RUO products to ensure adherence to established processes, policies and procedures.What will you do?
- Review complaints for regulatory reportability against internal policies and external guidance/regulations.
- Review and approve product labelling/marketing materials/promotional materials for compliance with applicable regulations and standards
- Participate in internal and external company regulatory/quality audits
- Participate in customer audits/technical meetings when applicable
- Support global registrations and submissions by gathering supporting documentation as required
- Regulatory assessment of on market product and process changes with respect to the activities carried out at the Warrington facility in the UK
- Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
- Assist the Regulatory department in the update, enhancement, and creation of internal policies and procedures or perform other activities as the need arises.
How you will get hereMinimum Requirements/Qualifications:
- Must have a minimum of 2 years within the IVD industry including Regulatory Affairs or Quality Assurance experience. Must be well versed in the aspects of regulatory submissions, design control, and cGMP/Quality Systems.
- Experience in the balance and application of regulatory requirements.
- Review of promotional marketing materials, advertising, labeling, etc.
- A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.
- Experience working across multiple manufacturing sites is recommended.
What’s in it for you?
At Thermo Fisher Scientific, each one of our 90,000 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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