Sr Regulatory Analyst, Animal Health
When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $18 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Senior Regulatory Analyst
The Senior Regulatory Analyst will be responsible for supporting Animal Health In-Vitro Diagnostic / Medical Device regulatory activities in EMEA, with an emphasis for Poland, Germany and Eastern Europe.
The incumbent will work in Global Regulatory Affairs department to establish and maintain appropriate systems to ensure Regulatory Compliance consistent with national, federal and international law and act as a strategic partner to AgriBusiness within Thermo Fisher Scientific.
- Subject matter expert on various regulations related to our Animal Health In-Vitro Diagnostics portfolio, as well as coordinate issue resolution through the use of outside consultants, regulatory agencies, and / or internal resources.
- Primary liaison with regulatory authorities in Poland and Eastern Europe primarily, Germany.
- Prepare regulatory submissions for Regulatory Authorities in countries as required.
- Prepare product regulatory submissions and assist in activities to support the approved products during their lifecycle (i.e. variations due to changes, reporting issues to the Authorities, as well as support annual compliance audits).
- Prepare and maintain establishment registration and listings as needed.
- New Product Introduction programs - RA representative in Core Teams: Complete product regulatory assessments and plans for New Product Introduction programs, and drive execution.
- Obtain regulatory permits, including import / export clearance requirements and regulations, in support of animal products including compliance.
- Labeling / marketing material and contracts review.
- Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
- Conduct training and/or communicate appropriate material to internal staff to aid in compliance.
- Develops regulatory affairs internal policies and procedures, and provide compliance training.
- May perform audits, both physical and paper, to ensure compliance with various regulations.
- May coordinate audit through outside vendor/distributor.
REQUIREMENTS / EDUCATION:
- Must have a minimum of 5 years of Regulatory Affairs In-Vitro Diagnostic Medical Device or Animal Health work experience, or an equivalent combination of education and experience. Regulatory certification is a plus.
- English and Polish are mandatory, German and Cyrillic are expected.
- In-Vitro Diagnostic/Medical Device regulatory affairs; Animal or Human Diagnostic ; Animal Diagnostic submissions (i.e. 510(k), PMA, IDE), cGMP/Quality Systems, Regulatory Compliance and Import/Export regulations.
- Direct and positive experience in communicating with Regulatory Authorities (e.g. PIWet, FLI) and Distributors.
- Multi-site experience, in a mid to large size company.
- Requires the ability to provide solutions based on their own knowledge and industry experience base.
- Some travel is required.
- A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science. M.S. or M.B.A. is a plus.
At Thermo Fisher Scientific, each one of our 50,000 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. Apply today http://jobs.thermofisher.com
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