Regulatory Affairs Associate II
3 weeks ago
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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Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full timeThe Regulatory Affairs Specialist plays a vital role within the Global Regulatory Affairs team, focusing on the registration of 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 documents, and the meticulous...
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