Careers at ThermoFisher Scientific

Apply Now >>    
Job ID :
Location :
Netherlands - Lelystad
Job Description

Position Objective:

The Regulatory Analyst based on Lissieu site France or alternatively on Lelystad-Platinastraat site Netherlands is responsible for managing Veterinary Diagnostics regulatory submission and regulatory compliance activities in line with corporate and divisional objectives.

Essential Functions:

• Compile and review regulatory submissions, Technical Files, and labeling for completeness and quality, according to RA team strategy and plan.

• Maintain and update dossiers for existing Marketing Authorisations. In particular, participate in the (re-) registration for LSG Integration in accordance with directions and timelines to be determined by Global Regulatory.

• Determines the scope of information/documentation necessary to file new registration applications and post-approval changes to regulatory agencies.

• Ensures regulatory project deadlines and performance standards are established and met.

• Maintain regulatory records and trackers.

• Review Products material (Instructions for Use, labels, validation report etc.) / any customer-facing material, for compliance with applicable regulations and standards, including corporate policies.

• Review new and existing EMEA regulatory guidance documents, and prepare comments on new documents as needed.

• Participate in Project Teams and New Product Introduction Teams. Identifies regulatory requirements for new product and changes to existing products.

• Ensure regulatory compliance for products manufactured on Lissieu and/or Lelystad manufacturing site. In particular, maintain proper products set-up in the corporate systems and tools in place.

• May be required to perform other related duties as required and/or assigned.


Requires a Bachelors Degree in biology, chemistry, biochemistry, microbiology, or related discipline.


Requires a minimum of 3-5 years of professional experience in IVD/Medical Devices and/or Animal Health Diagnostics Regulatory Affairs.

Excellent understanding of the European Animal Health regulatory affairs environment: Regulations, Submissions, Technical Files, Quality Systems, Compliance and Import/Export regulations.

Participation and experience in regulatory audits, ISO certification, and document control.

Computer literacy, including spreadsheet, database and word processing applications as well as the Internet required.

Language Skills: Native French and a good level of English is a minimum. Spanish would be highly appreciated.


Must interface with many levels of management in a widely varied cultural mix worldwide.

Has contact with all levels of company employees as well as frequent interactions with varies external regulatory agencies, authorities, distributors and customers.

Working Conditions:

Works in an office environment. May require some travel: < 25%.

Apply Now >>    
Join our Talent Community

If you're ready to make a difference in the world, you can do it here.

Refer a friend

Already work here? Help us write our next chapter

Refer Now


5 Reasons to Work at Thermo Fisher Scientific
Search Jobs by Map