Regulatory Affairs Specialist

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

Job summary

An established industry player is seeking a Regulatory Affairs Specialist to ensure compliance with FDA regulations and manage regulatory submissions. This role involves liaising with external regulatory bodies, coordinating compliance efforts across internal teams, and contributing to the development of regulatory strategies. The ideal candidate will possess a degree in Life Sciences and have proven experience in regulatory affairs, along with excellent communication and organizational skills. Join this innovative firm and play a key role in the development of cutting-edge medical devices.

Qualifications

• Proven experience in regulatory affairs with a solid understanding of FDA regulations.
• Strong attention to detail and the ability to manage multiple projects.

Responsibilities

• Ensuring compliance with FDA regulations and managing regulatory submissions.
• Liaising with external regulatory bodies and coordinating internal compliance.

Skills

Regulatory Affairs

FDA Regulations

Communication Skills

Organisational Skills

Problem-Solving

Education

Degree in Life Sciences

Job description

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Regulatory Affairs Specialist, Manchester

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Client:

Page Personnel

Location:

Manchester, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

462a871dfc9a

Job Views:

3

Posted:

05.05.2025

Expiry Date:

19.06.2025

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Job Description:

• Fantastic opportunity to join a leading medical devices manufacturer
• Fantastic opportunity to work with NPD lines

About Our Client

My client is a leading medical device manufacturer within the beauty/tech space with innovative new product development lines and existing portfolio.

Job Description

• Ensuring compliance with FDA regulations and standards.
• Managing all regulatory submissions and documentation.
• Liaising with external regulatory bodies.
• Coordinating with internal teams to ensure company-wide compliance.
• Staying up-to-date with changes in regulatory legislation and guidelines.
• Contributing to the development of regulatory strategies.
• Providing training and support to staff on regulatory issues.
• Participating in audits and inspections.

The Successful Applicant

A successful Regulatory Affairs Compliance Specialist should have:

• A degree in Life Sciences or a related field.
• Proven experience in regulatory affairs.
• A solid understanding of FDA regulations and guidelines.
• Excellent communication and organisational skills.
• The ability to manage multiple projects simultaneously.
• Strong attention to detail and problem-solving abilities.