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Regulatory Affairs Specialist Jobs (Biotech)

Experts who ensure biotech products meet legal and safety standards. A critical role in bringing new therapies and technologies to market.

Open roles
3
Salary range
£42k – £55k
Hiring companies
2
View 3 live roles → Get an alert

Regulatory Affairs Specialists in biotechnology play a crucial role in ensuring that new drugs, therapies, and biotech products comply with regulatory requirements. Working closely with scientists, clinicians, and legal teams, these professionals navigate the complex landscape of national and international regulations to bring safe and effective products to market. They are essential in the development and commercialisation process, from early-stage research to post-market surveillance.

What the role does

Inside the role of a Regulatory Affairs Specialist

A typical week is split between reviewing documentation, liaising with regulatory bodies, and collaborating with cross-functional teams.

  1. 01
    Review and prepare regulatory submissions and documentation.
  2. 02
    Liaise with regulatory agencies to address queries and provide updates.
  3. 03
    Collaborate with R&D and clinical teams to ensure compliance.
  4. 04
    Monitor and report on regulatory changes and trends.
  5. 05
    Conduct internal audits and quality assessments.
  6. 06
    Prepare for and attend regulatory inspections and meetings.
Salary on the board

£42k – £55k

Based on advertised midpoints across the 3 priced listings posted in the last 12 months. Base salary only.

By seniority
£k base
Mid
42
50
2 jobs
Skills & tools

What hiring managers ask for

% of 3 listings posted in the last 12 months that mention each skill, extracted from job descriptions.

Regulatory Affairs
100%
Medical Devices
100%
ISO 13485
67%
Compliance
67%
UK MDR
33%
EU MDR
33%
Technical Documentation
33%
Post-Market Surveillance
33%
Clinical Evaluation
33%
Risk Management
33%
Regulatory Submissions
33%
ISO 9001
33%
Career ladder

From Junior to Principal

A typical UK progression for regulatory affairs specialists. Years are guidance — strong people move faster, and many senior folks sidestep into research, product or management.

  1. Level 1

    Junior Regulatory Affairs Specialist

    0–2 yrs

    Assists in the preparation of regulatory submissions and supports the team with documentation and compliance tasks.

  2. Level 2

    Regulatory Affairs Specialist

    2–5 yrs

    Takes ownership of specific regulatory submissions and works independently on compliance projects.

  3. Level 3

    Senior Regulatory Affairs Specialist

    5–8 yrs

    Leads the preparation and submission of complex regulatory documents and manages relationships with regulatory agencies.

  4. Level 4

    Principal Regulatory Affairs Specialist

    8+ yrs

    Strategises and oversees the entire regulatory affairs function, ensuring compliance and driving regulatory strategy.

Pathway

How to become a Regulatory Affairs Specialist

There's no single route, but most people follow some version of these steps.

  1. 1

    Entry-Level Role

    Start as a Junior Regulatory Affairs Specialist, learning the basics of regulatory compliance and documentation.

  2. 2

    Specialist Role

    Progress to a Regulatory Affairs Specialist, taking on more responsibility for specific projects and submissions.

  3. 3

    Senior Role

    Advance to a Senior Regulatory Affairs Specialist, leading complex regulatory initiatives and managing agency relationships.

  4. 4

    Principal Role

    Achieve the Principal Regulatory Affairs Specialist level, where you will oversee the entire regulatory affairs function and drive strategic initiatives.

  5. 5

    Leadership Role

    Potentially move into a leadership position, such as a Director of Regulatory Affairs, managing a team and setting the overall regulatory strategy.

Live jobs

3 live roles

Regulatory Affairs Specialist

This role involves maintaining technical documentation and ensuring compliance with UK and EU MDR regulations for Class I and IIa medical devices. The specialist will support regulatory submissions, post-market surveillance, and quality management system development within a regulated environment. Collaboration with the QA Manager and ongoing product lifecycle support are key aspects of the position.

Cure Talent Upper Marlbrook, Worcestershire, B61 0RT, United Kingdom £45,000 – £50,000 pa
On-site Permanent
Newton Colmore logo

Regulatory Affairs Specialist - Medical Devices

This role involves leading quality assurance and regulatory affairs initiatives within a global medical devices company, working across European, American, and Asian regulatory standards. You will develop and implement solutions for compliance and management systems in a highly technical R&D and manufacturing environment. The position offers exposure to emerging regulated industries and complex, international projects.

Newton Colmore Cambridge, Cambridgeshire, United Kingdom £42,000 – £46,000 pa
On-site Permanent
Newton Colmore logo

Regulatory Affairs Specialist - Medical Devices - Cambridge

This role involves providing regulatory expertise to guide product development across medical and non-medical technologies, ensuring compliance with international standards such as ISO 13485, FDA 21 CFR 820, and ISO 9001. The specialist will work embedded within project teams, interpreting evolving regulations, supporting quality systems, and enabling innovation while maintaining regulatory alignment throughout the product lifecycle.

Newton Colmore Cambridge, Cambridgeshire, United Kingdom
On-site Permanent
Hiring locations

Where this role is hiring

The locations with the most live listings for this role today.

Cambridge

Location
2 open
FAQs

Common questions

  • A relevant degree in a life science or related field, along with experience in regulatory affairs, is typically required. Professional certifications like RAC (Regulatory Affairs Certification) are also valuable.

  • Strong attention to detail, excellent communication skills, and the ability to navigate complex regulatory frameworks are crucial. Project management and collaboration skills are also important.

  • In smaller companies, the role may be more hands-on and involve a broader range of responsibilities. In larger companies, the role is often more specialised, with a focus on specific therapeutic areas or regulatory regions.

  • Working hours are generally standard office hours, but deadlines and regulatory submissions can require occasional overtime or flexible hours.

  • Salaries can vary widely based on experience, location, and company size. For more detailed salary information, please refer to the salary section on this page.

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