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Regulatory Affairs Specialist Jobs (MedTech)

Experts who ensure medical devices and health-tech products comply with stringent regulatory standards. A critical role in bringing safe, effective innovations to market.

Open roles
2
Salary range
£35k – £60k
Hiring companies
2
View 2 live roles → Get an alert

Regulatory Affairs Specialists in the medical technology sector play a vital role in ensuring that medical devices, health-tech software, and diagnostic systems meet the rigorous standards set by regulatory bodies such as the MHRA and the EU. These professionals work closely with cross-functional teams, including engineers, clinicians, and quality assurance, to navigate the complex landscape of regulatory requirements. They are responsible for preparing and submitting regulatory documentation, conducting gap analyses, and maintaining compliance throughout the product lifecycle.

What the role does

Inside the role of a Regulatory Affairs Specialist

A typical week is split between document preparation, regulatory strategy development, and stakeholder communication.

  1. 01
    Review and update regulatory documentation
  2. 02
    Conduct gap analyses and risk assessments
  3. 03
    Collaborate with cross-functional teams on compliance issues
  4. 04
    Prepare and submit regulatory submissions
  5. 05
    Monitor and report on regulatory changes
  6. 06
    Engage with regulatory bodies and external consultants
Salary on the board

£35k – £60k

Based on advertised midpoints across the 14 UK listings priced in pounds in the last 12 months. Base salary only.

Salary visibility
7% of listings advertise a salary — up from 0% the year before.
By seniority
£k base
Mid
38
55
6 jobs
Skills & tools

What hiring managers ask for

% of 19 listings posted in the last 12 months that mention each skill, extracted from job descriptions.

Regulatory Affairs
84%
Medical Devices
74%
ISO 13485
47%
Regulatory Submissions
32%
Regulatory Strategy
21%
Compliance
21%
Quality Assurance
21%
SOP Development
16%
Post-Market Surveillance
16%
EU MDR
16%
Project Management
16%
Technical Documentation
16%
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 compliance activities under supervision.

  2. Level 2

    Regulatory Affairs Specialist

    2–5 yrs

    Takes ownership of regulatory submissions and gap analyses, and begins to lead compliance activities.

  3. Level 3

    Senior Regulatory Affairs Specialist

    5–8 yrs

    Leads regulatory strategy development and manages complex regulatory projects, often mentoring junior team members.

  4. Level 4

    Principal Regulatory Affairs Specialist

    8+ yrs

    Oversees the entire regulatory function, advises senior management on regulatory strategy, and represents the company in interactions with regulatory bodies.

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 regulatory submissions and compliance activities.

  3. 3

    Senior Role

    Advance to a Senior Regulatory Affairs Specialist, leading regulatory projects and mentoring junior team members.

  4. 4

    Principal Role

    Achieve the Principal Regulatory Affairs Specialist level, overseeing the regulatory function and advising senior management.

  5. 5

    Strategic Leadership

    Move into a strategic leadership role, shaping the company's regulatory strategy and representing the company in high-level regulatory discussions.

Live jobs

2 live roles

Newton Colmore logo

Newton Colmore · 11–50 people

Regulatory Affairs Specialist - Medical Devices - Cambridge

  • Cambridge
  • Mid-level

Provide regulatory support across a Cambridge product development business, guiding multidisciplinary engineering and science teams on compliance with ISO 9001, ISO 13485 and FDA 21 CFR 820. Monitor international regulatory changes, support external audits and contribute to quality management system improvements across medical and non-medical projects.

3 weeks ago

L-ev8 Recruitment Ltd

Senior Quality & Regulatory Affairs Specialist

  • Burgess Hill
  • £50,000 pa
  • Senior
  • Part time

Part-time role maintaining quality and regulatory compliance for a Class I(s) medical device manufactured by an approved contract manufacturer. You will oversee supplier quality, review batch documentation, validation and change control, maintain technical files, and support audits, vigilance and post-market surveillance, working closely with the Head of Quality and sharing PRRC responsibilities.

3 weeks ago
Hiring locations

Where this role is hiring

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

Cambridge

Location
1 open
FAQs

Common questions

  • A relevant degree in a life science or engineering discipline, along with professional certifications such as RAC, is highly valued.

  • Experience in the medical technology industry is crucial, as it provides a deep understanding of the specific regulatory requirements and industry practices.

  • Strong attention to detail, excellent communication skills, and the ability to navigate complex regulatory frameworks are essential.

  • Career progression typically follows a path from Junior to Principal Regulatory Affairs Specialist, with opportunities to move into strategic leadership roles.

  • For specific salary information, please refer to the salary section on this page.

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