Regulatory Affairs Specialist

Job title:

Regulatory Affairs Specialist

Company

Thermo Fisher Scientific

Job description

Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob DescriptionWe are looking for a Regulatory Affairs Specialist to join our team in Vantaa. As a Regulatory Affairs Specialist you will be a crucial part of the Biomarkers, Automation and Instrumentation team, managing regulatory submissions and documentation. Your expertise will help implement successful regulatory strategies.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.
• Reviews product and manufacturing changes for compliance with applicable regulations and submits change notifications when applicable.
• Builds and implements departmental policies and procedures.
• Supports primarily Clinical chemistry product lines, new product development projects

How will you get there

• M.Sc. or B.Sc. degree in Engineering, Biochemistry, or equivalent experience.
• Experience working with quality system requirements (ISO13485, EU IVDR/IVDD, or FDA QSR) and with in vitro diagnostic medical device or related field for two years.
• Effective interpersonal skills, strong written and verbal communication, and presentation skills.
• Shown time management skills to prioritize multiple ongoing projects simultaneously.
• Strong analytical and problem-solving skills.
• Ability to coordinate and work optimally with cross-functional teams.
• Ability to readily adjust to change in a fast-paced environment and multitask.
• Ability to communicate efficiently with experts in other scientific and technical fields.
• Ability to reach solutions with confidence and integrity.

Please send in your application, including a cover letter, CV and salary request in English. Please apply via by 4th of May 2025. Reference: R-01313340. Please apply as soon as possible, the position will be filled as soon as suitable candidate is found.If you have questions about Thermo Fisher Scientific and/or the position – please contact Petra Norrman, Recruiter Nordics, petra.norrman@thermofisher.com.About us:Each one of our 130,000 extraordinary minds has a unique story to tell. It’s not just a career, it’s a chance to realise your best – professionally and personally.Join us and contribute to our mission—enabling our customers to make the world healthier, cleaner and safer:

Expected salary

Location

Suomi

Job date

Wed, 16 Apr 2025 22:00:32 GMT

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