Regulatory Affairs Specialist II

TN United Kingdom; Birmingham; On-site; GBP 40,000 - 70,000; Full time

Job summary

An innovative organization is seeking a Regulatory Affairs Specialist to join their Global RA team in Birmingham. The role involves preparing and submitting regulatory documentation for PDx products across various global markets, ensuring compliance with local regulations. You will track registrations, support audits, and promote process improvements to enhance regulatory efficiency. This position offers competitive remuneration and a range of employee benefits, making it an exciting opportunity for those passionate about regulatory affairs and quality assurance.

Benefits

Healthcare

Annual incentive plan bonus

Employee benefits

Qualifications

• Degree in a related science required.
• Proven experience in a regulatory or quality environment.

Responsibilities

• Author and submit registration documentation.
• Track annual licenses and registrations.
• Act as Regulatory representative on project teams.

Skills

Regulatory submission documentation

Knowledge of ISO13485

Strong communication skills

Regulatory compliance

Education

Degree in Chemistry

Regulatory Qualification

Job description

Social network you want to login/join with:

Regulatory Affairs Specialist II, Birmingham

Client: Thermo Fisher Scientific

Location: Birmingham, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: c08e4acced59

Job Views: 6

Posted: 05.05.2025

Expiry Date: 19.06.2025

Job Description:

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 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.
• Approve change requests to ensure compliance and the requirements 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 RA processes.

Keys to Success:

Education

• 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 in preparing regulatory submission documentation.
• Strong interpersonal, verbal, and written communication skills.

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