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Job ID :
47897BR
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.

Education:

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

Experience:

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.

Contacts:

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%.



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