Regulatory Specialist III

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.

Key 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 orders
• Reviews product and manufacturing changes for compliance with applicable regulations and submits change notifications when applicable.
• Builds and implements departmental policies and procedures.
• Supervising/supporting Vantaa RA staff development
• Lead, motivate and guide associates in a matrix organization on industry-leading practices.
• Advise the business unit regulatory teams on the optimal regulatory strategies, submissions, and approval pathways.  Manage a complex and diverse set of registration/regulatory requirements across global markets to enable the product global registrations.
• Work across business units to establish best practices, efficiencies, and development for regulatory affairs.
• Partner with R&D, marketing, operations, and business leadership for delivering on agreed timelines and global commercialization approaches. Create strong and proactive relationships with cross-functional functions.
• Interact with Notified Bodies, FDA, & global regulatory authorities to gain alignment on regulatory strategies and resolve concerns to expedite approval of pending applications. Remain well-versed in evolving global regulatory policies and advise business units internally on anticipated changes, net business effect and develop appropriate strategies/processes to appropriately address.
• Oversee regulatory communications with marketing to ensure appropriate approval of commercial literature and language.

Requirements

• Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in regulatory affairs in the pharmaceutical, medical device, or diagnostics industry
• Preferred Fields of Study: life sciences, chemistry, engineering, pharmacy, or related scientific field
• Additional certifications like RAC (Regulatory Affairs Certification) advantageous
• Strong knowledge of global regulatory requirements, particularly FDA, EU MDR/IVDR, and other major markets' regulations
• Experience preparing and submitting regulatory filings (e.g., 510(k), CE marking, technical files)
• Demonstrated success in regulatory strategy development and implementation
• Expert understanding of quality systems (ISO 13485, GMP/QSR) and risk management principles
• Excellent project management skills with ability to manage multiple projects simultaneously
• Strong analytical and problem-solving capabilities
• Clear written and verbal communication skills
• Experience working effectively in cross-functional team environments
• Fluency in English required; additional languages beneficial
• Proficiency with regulatory submissions software and Microsoft Office suite
• Experience with change control and post-market surveillance activities
• Strong attention to detail and organizational skills
• Ability to interpret and apply complex regulatory requirements
• Customer-focused mindset with business acumen
• Available for occasional travel (10-20%)
• Effective interpersonal skills and ability to build consensus
• Experience supporting regulatory staff development preferred

Please send in your application, including a cover letter, CV and salary request in English. Please apply via http://jobs.thermofisher.com/ by 3rd of May 2026. Reference: R-01347911. Please apply as soon as possible, the position will be filled as soon as suitable candidate is found. The selected candidate will go through health check which includes a drug test.

If you have questions about Thermo Fisher Scientific and/or the position - please contact Petra Norrman, Recruiter Nordics, petra.norrman@thermofisher.com.

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