Regulatory Specialist III
About this role
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Our Finland locations include Vantaa and Joensuu, employing over 800 professionals in R&D, production, supply chain, quality, marketing, sales, and administrative support. We hire experts in different fields including engineering, chemistry, microbiology, and bioinformatics. Our Vantaa site develops laboratory automation solutions, clinical chemistry and industrial chemistry analyzers and assays, food safety kits, pipettes and other diagnostics and research solutions. It is conveniently located close to the Vantaankoski railway station. Please read more about Finnish sites, innovative work, and collaborative colleagues at https://jobs.thermofisher.com/global/en/finland.
How will you make an impact?
We are looking for an experienced Regulatory Affairs Specialist to join our team in Vantaa. As a Regulatory Affairs Specialist III, you will provide strategic regulatory guidance and expertise for product development, registration, and lifecycle management across our diverse portfolio. You will collaborate with cross-functional teams to develop and implement regulatory strategies that enhance time-to-market while maintaining the highest standards of compliance.
Responsibilities
- Develops and implements regulatory strategies for new and modified products.
- Plans, coordinates and prepares document packages for global regulatory submissions.
- Acts as company representative, developing and maintaining positive relationships with authorities through oral and written communications regarding submission pathway development, clarification, and follow-up of submissions under review.
- Acts as a core team member on product development, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
- Preparation and maintenance of product technical files for CE marking
- Maintaining trackers for Vantaa site
- Review/approve change or