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 $17 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 U.S. and International Animal Health In-Vitro Diagnostic Medical Device regulatory activities. The incumbent will work in Global Regulatory Affairs department to establish and maintain appropriate systems to ensure Regulatory Compliance consistent with state, federal and international law.
- As the site regulatory expert, the incumbent is required to provide leadership and training to assure that all regulatory submissions and compliance matters are planned, communicated and executed per regulatory and business requirements.
- Subject matter expert on various regulations as well as coordinate issue resolution through the use of outside consultants, regulatory agencies, and / or internal resources.
- Prepare USDA product regulatory submissions and assist in activities to support the approved products during their lifecycle (i.e. updates to labeling, reporting issues to the USDA, as well as support annual compliance audits).
- Prepare regulatory submissions for health authorities in other countries as required.
- Prepare and maintain state and federal licensing, establishment registration and listings as needed.
- Obtain regulatory permits, including import / export clearance requirements and regulations, in support of animal products including compliance with the European regulation EC 1069.
- Support for this regulation includes facilitating USDA annual inspections for the Austin site as well as supporting Thermo Fisher’s other manufacturing sites that require USDA inspection in order to export products that contain animal components to the EU.
- Complete product regulatory assessments of new and changed products. Labeling / marketing material review.
- Participate in Project Teams and New Product Introduction Teams.
- 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.
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.
- In-Vitro Diagnostic/Medical Device regulatory affairs: USDA or FDA Regulations; Animal or Human Diagnostic (Animal Diagnostic submissions, 510(k), PMA, IDE), cGMP/Quality Systems, Regulatory Compliance and Import/Export regulations.
- Direct and positive experience in communicating with Regulatory Authorities 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
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.