Regulatory Affairs Specialist II

7 days ago


Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

The Regulatory Affairs Specialist at Thermo Fisher Scientific plays a critical role in the Global RA team, responsible for the registration of PDx products in global markets. This includes interpreting local regulatory requirements, preparing submission documentation, and tracking registrations to completion.

A Day in the Life:

  • Author, compile, and submit registration documentation to ensure alignment with regional regulations.
  • Track and maintain files for annual licenses, registrations, and listings with Regulatory Authorities.
  • Identify, collect, and apply information on local regional regulatory intelligence and other related information through involvement in Industry associations.
  • Approval of change requests to ensure compliance and the requirement for regulatory submissions.
  • Act as Regulatory representative on project teams, providing regulatory expertise and mentorship.
  • Support external and internal site audits, perform RA reviews, and ensure compliance with company policies and regulations (including MDSAP and ISO13485).
  • Promote a process improvement culture through PPI activities to improve quality and efficiency of the RA processes.

Keys to Success:

Education

  • Bachelor's degree in Chemistry, Biology, Biochemistry, or a related science required.
  • Regulatory Qualification is an advantage.

Experience

  • Proven experience in a regulatory or quality environment.

Knowledge, Skills, Abilities

  • Knowledge of ISO13485, MDSAP, and ISO9001.
  • Experience of preparing regulatory submission documentation.
  • Strong interpersonal, verbal, and written communication skills.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.



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