Jobs for People with MS: National MS Society

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

We 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 software, instrument, and automation product lines, new product development projects, or central initiatives.

How will you get there

• M.Sc. or B.Sc. degree in Software Engineering, 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.

• Understanding about Software as a Medical Device (SaMD) or at least an approach passionate about software.

• 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 http://jobs.thermofisher.com/ by 22nd of September 2024. Reference: R-01274833. 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: 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.