Regulatory Affairs Associate II

3 weeks ago


Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

The Regulatory Affairs Specialist plays a crucial role within the Global Regulatory Affairs team, focusing on the approval processes for PDx products across various international markets, including EMEA, USA, LATAM, and AsiaPac. This position involves a thorough understanding of local regulatory frameworks, the preparation of submission materials, and the diligent tracking of product registrations until completion.

Daily Responsibilities:

  • Develop, compile, and submit registration documentation to ensure compliance with regional regulations.
  • Maintain and organize files for annual licenses, registrations, and listings with Regulatory Authorities.
  • Gather, analyze, and apply insights on local regulatory intelligence and related information through active participation in industry associations.
  • Review and approve change requests to ensure adherence to compliance requirements for regulatory submissions.
  • Serve as the Regulatory representative on project teams, offering regulatory expertise and guidance.
  • Assist in external and internal site audits, conduct Regulatory Affairs reviews, and ensure alignment with company policies and regulatory standards (including MDSAP and ISO13485).
  • Foster a culture of process improvement through participation in PPI initiatives, aimed at enhancing the quality and efficiency of Regulatory Affairs processes.

Essential Qualifications:

Education:

  • A degree in Chemistry, Biology, Biochemistry, or a related scientific discipline is required.
  • Regulatory Qualification is considered an asset.

Experience:

  • Demonstrated experience in a regulatory or quality assurance environment.

Knowledge, Skills, and Abilities:

  • Familiarity with ISO13485, MDSAP, and ISO9001 standards.
  • Experience in preparing regulatory submission documentation.
  • Excellent interpersonal, verbal, and written communication skills.

Employee Benefits:

We provide competitive compensation, an annual incentive plan, comprehensive healthcare, and a variety of employee benefits. Thermo Fisher Scientific offers a dynamic and innovative work environment, along with exceptional career development opportunities. Our company culture emphasizes integrity, intensity, involvement, and innovation.



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