Regulatory Affairs Specialist

JR United Kingdom; Cambridge; On-site; GBP 60,000 - 80,000; Full time

Job summary

An exciting opportunity awaits at a dynamic Diagnostics company specializing in Gastrointestinal Cancer. They are seeking a Regulatory Affairs Specialist to join their dedicated team. This role focuses on regulatory submissions, risk management, and compliance with standards like ISO 13485, MDR, and IVDR. The ideal candidate will bring strong regulatory knowledge, excellent organizational skills, and experience in preparing technical documentation. Join a forward-thinking firm where your contributions will play a vital role in the development of innovative medical solutions. If you are passionate about regulatory affairs and eager to make an impact, this position is perfect for you.

Qualifications

• Proven experience in Regulatory Affairs within Medical Devices.
• Familiarity with ISO 13485, MDR, and IVDR requirements.

Responsibilities

• Support regulatory submissions, including Technical Files and Design Dossiers.
• Assist with clinical study documentation and risk management.

Skills

Regulatory Affairs

Risk Management

Technical Documentation

Communication Skills

Quality Management Systems (QMS)

Education

Scientific Degree

Tools

ISO 13485

MDR

IVDR

Job description

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Regulatory Affairs Specialist, Cambridge

Client:

Cure Talent

Location:

Cambridge

Job Category:

Other

EU work permit required:

Yes

Job Views:

1

Posted:

30.03.2025

Expiry Date:

14.05.2025

Job Description:

Cure Talent are delighted to be partnered with an exciting Diagnostics company, specialising in Gastrointestinal Cancer, who, due to their continued growth, have an exciting opportunity for an experienced Regulatory Affairs Specialist to join their dedicated team.

This role will primarily focus on Regulatory Affairs, supporting the preparation and maintenance of regulatory submissions, risk management, and ensuring compliance with relevant standards such as ISO 13485, MDR, and IVDR. It will also include limited Quality Assurance responsibilities focused on QMS maintenance and audit support.

The ideal candidate will have strong regulatory knowledge, experience preparing technical documentation, and familiarity with risk management and post-market surveillance processes. Effective communication skills and the ability to work cross-functionally are essential.

Key Responsibilities:

• Support the preparation and maintenance of regulatory submissions, including Technical Files and Design Dossiers
• Assist with clinical study documentation, risk management, and reports
• Maintain knowledge of ISO 13485, MDR, and IVDR requirements
• Provide support for new product development and registration activities
• Maintain Risk Management Files, PMS reports, and labelling requirements
• Assist in internal audits and support audit preparation
• Support the implementation of the company’s eQMS

The ideal candidate will have:

• A scientific degree or equivalent industry experience
• Proven experience in Regulatory Affairs within Medical Devices
• Familiarity with ISO 13485, MDR and/or IVDR requirements
• Experience preparing technical documentation and supporting regulatory submissions
• Excellent organisational and communication skills

If you have the necessary skills and experience to be successful in this role, please get in touch with the team at Cure Talent today!