Job Information
ThermoFisher Scientific Regulatory Affairs Specialist in Finland
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Thermo Fisher Scientific Inc. is seeking a highly motivated individual with strong work behaviors to join our team as a Regulatory Affairs Specialist. As the world leader in serving science, with annual revenue of approximately $40 billion, we are dedicated to enabling our customers to make the world healthier, cleaner, and safer. With our innovative technologies and industry-leading brands, including Thermo Scientific, Applied Biosystems, Fisher Scientific, and more, we are committed to providing world-class solutions to our customers.
About Finland
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
The Regulatory Affairs (RA) Specialist coordinates product registrations in connection with our commercial organization and distributors. RA specialist provides regulatory support to product sustaining activities.
Essential tasks, responsibilities and authorizations
Registration of in vitro diagnostic medical devices
Coordinate, prepare and submit marketing authorization applications in market areas.
Coordinate, create and compile supporting documentation packages for marketing authorizations.
Support requests for additional information from the Competent Authorities
Coordinate and conduct re-registrations
Regulatory information systems
Implementation and maintenance of registration data in regulatory information management system
Implement and maintain SAP licenses and handling of default order blocking
Operate the EUDAMED system
Vigilance reporting (adverse events and field safety corrective actions)
- Substitute in filing vigilance reports and additional information requests.
IVD products
Support new product development!
Perform regulatory assessment of proposed changes
Conduct change notifications globally
Take part to product legal compliance (PLC) activities as RA SME
Other technical and/or administrative tasks
Follow regulatory information within relevant scope.
Act as Subject Matter Expert (SME), including the creation and signature of statements or declarations in own area of expertise
Provide support and/or training on related regulations and registration requirements
Perform SOP updates as necessary
Undertake document legalization when needed
Follow applicable procedures, including the Quality Management System (QMS)
Initiate and participate in process and/or QMS improvement activities in own area of expertise
Take part to external and internal audits as necessary
Represent RA in cross-functional teams and activities
Perform other related tasks as required by the superior(s)
Minimum Requirements/Qualifications for Education
- M.Sc. or B.Sc. degree in pharmacy, microbiology, biology, analytical chemistry, biochemistry, engineering or related field.
Minimum Requirements for Experience and Skills
Experience from working with quality system requirements (ISO13485, EU IVDR/IVDD or FDA QSR) and with in vitro diagnostic medical device or related field for five years, or three years with an advanced degree.
Attention to detail in setting, conducting, and documenting; records keeping in compliance with company policy and regulatory requirements (e.g. IVD Directive/Regulation and USA FDA QSR; ISO 13485, Health Canada)
Excellent verbal and written communication skills in Finnish and English
PC literacy including MS Office and Outlook
Good analytical and problem-solving skills
Ability to communicate efficiently with the experts in the other scientific and technical fields
Ability to reach solution with confidence and integrity
In addition to the interesting and versatile job, we offer:
Compensation on various methods from annual bonus scheme to colleague recognition program
Variety of occupational health care services and insurance
Possibility to work remote with agile and mobile working methods
Epassi leisure benefit
Various hobby clubs with company sponsorship such as golf club, boating club, sport club etc.
Possibility to take part in our charity work
Career development and progression possibilities offered by our global network
Our comprehensive training platform and programs
Be part of our mission to enable our customers to make the world healthier, cleaner and safer
Please send in your application, including a cover letter, CV and salary request in English. Please apply via http://jobs.thermofisher.com/ by 30th of June 2024. Reference: R-01245745. 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.