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Job ID :
59044BR
Location :
United Kingdom - Basingstoke
:
Job Description
Job Title: Regulatory Affairs Specialist
Position Location: Basingstoke

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 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.

Position Summary:

Thermo Fisher Scientific is seeking an experienced Regulatory Affairs professional to assist with the maintenance of current product registrations, define and implement regulatory strategy for new products and to ensure continuing regulatory compliance. The Regulatory Affairs Specialist will report to the Global Regulatory Affairs Manager for Microbiological Culture Media.

Responsibilities:

  • Develop and implement regulatory strategy across projects to ensure that company products are safe, legal and meet expectations for compliance with applicable 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.
  • Ability to provide regulatory guidance and assistance to all Microbiology Division media facilities with regards to regulatory compliance
  • Assist with preparation and submission of required submissions to Foreign Governments.
  • Review promotional information and product literature to ensure regulatory compliance
  • Review governmental rulings to determine changes and probable effects on facility activities
Minimum Qualifications/Experience:
  • Degree in Medical/Pharmaceutical Regulatory Affairs or related bioscience field including Microbiology and Chemistry.
  • Knowledge of IVD Directive (98/79/EC), US 21 CFR Part 820 and 510(k) submission process and applicable ISO Standards.
  • Substantial experience within the IVD or medical device industry
  • Excellent IT skills
Preferred Skills/Experience:
  • 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
  • Perform duties in accordance with established company procedures and policies; perform other duties as assigned.
  • Current full Driving License
*IND-EMEA


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