Regulatory Affairs Specialist II

Thermo Fisher Scientific
Birmingham
8 months ago
Applications closed

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The Regulatory Specialist works in the Global RA team and is responsible for the registration of PDx products in global markets including EMEA, USA, LATAM and AsiaPac. 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 it aligns with regional regulations. Track and maintain files for annual licences, 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

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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