Thermo Fisher Scientific Job - 31454656 | CareerArc
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Company: Thermo Fisher Scientific
Location: Dartford, England, United Kingdom
Career Level: Associate
Industries: Healthcare, Pharmaceutical, Biotech

Description

Job Title: Regulatory Affairs Specialist
Requisition ID: 110780BR

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 75,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.

Location/Division Specific Information

UK - Dartford
Job Title: Regulatory Affairs Specialist


How will you make an impact?

  • Develop and implement regulatory strategy across projects to ensure that company products are safe, legal and meet expectations for compliance with national and global regulations
  • Maintain and improve upon processes to ensure compliance with required regulatory standards and governing bodies
  • Generate records and documentation for inclusion into Technical Files and global regulatory submissions
  • Monitor and maintain government regulatory registration databases
  • Represent the Regulatory Affairs function at multi-departmental meetings
  • Liaise with competent authorities and notified bodies to seek advice and guidance when necessary.
How will you get here?
Minimum Qualifications/Experience:
  • Degree in Life Sciences or Engineering
  • Three years' experience within the IVD or medical device industry
  • Excellent IT skills
Preferred Skills/Experience:
  • Knowledge of IVD Directive (98/79/EC) and US 510(k) submission process
  • Experience of working with active devices (IEC 60601, IEC 61010, IEC 62304
  • Excellent attention to detail
  • Ability to plan multiple tasks and effectively prioritize activities
  • Effective communicator with management, peers and internal customers
  • Capability to drive assignments to completion
  • Good planning and organizational abilities
  • Pro-active with proven ability to work under own initiative, and strong team player
  • Current full Driving License.
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com




Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! 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.



To Apply, please click the following link: https://thermofisher.contacthr.com/73736166


 Apply on company website