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