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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
7
Salary range
£35k – £60k
Hiring companies
6
View 7 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 11 priced listings posted in the last 12 months. Base salary only.

Salary visibility
4% of listings advertise a salary.
By seniority
£k base
Mid
38
54
7 jobs
Skills & tools

What hiring managers ask for

% of 15 listings posted in the last 12 months that mention each skill, extracted from job descriptions.

Regulatory Affairs
80%
Medical Devices
67%
ISO 13485
47%
Regulatory Submissions
40%
SOP Development
20%
EU MDR
20%
Project Management
20%
Compliance
20%
Technical Files
20%
Global Regulations
13%
Regulatory Strategy
13%
Post-Market Surveillance
13%
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

7 live roles

Regulatory Affairs Specialist

This role involves maintaining regulatory compliance for medical devices by managing technical documentation, product registrations, and post-market surveillance activities. The specialist will work independently in an SME setting, ensuring adherence to UK and EU regulations including MDR, MDD, and UKCA. Responsibilities include updating clinical evaluations, supporting audits, and managing documentation with a focus on accuracy and efficiency.

ProTech Recruitment Ltd Hertford, Hertfordshire, United Kingdom £35,000 – £40,000 pa
Hybrid Permanent Part-time

Regulatory Affairs Specialist

This role involves ensuring product compliance with UK and international regulations, particularly in food contact materials and packaging legislation. The specialist will interpret evolving regulatory requirements, assess compliance for raw materials and finished products, and support new product development. Collaboration with technical, R&D, production, and commercial teams is central to providing practical regulatory solutions that align with business objectives.

Cranleigh Scientific Carlisle, Cumbria, CA3 8LU, United Kingdom

Regulatory Affairs Specialist

Our client:* A global leader in ingredient solutions, supporting innovation across food, beverage, and nutrition markets.* Driving growth through strategic partnerships with retailers, manufacturers, and health-focused brands.* Renowned for high-quality, functional ingredients that help brands meet evolving consumer needs.The role:*...

Seven London, United Kingdom
Newton Colmore logo

Regulatory Affairs Specialist - MedTech + More

Regulatory Affairs Specialist - MedTechA growing medical devices company in Cambridgeshire are currently in need of an experienced quality assurance and regulatory affairs specialist.This is an excellent opportunity for a QARA specialist to join this team of experts and work...

Newton Colmore Cambridge, Cambridgeshire, United Kingdom £45,000 – £49,000 pa
Newton Colmore logo

Regulatory Affairs Specialist - Medical Devices - Cambridge

This role involves providing regulatory guidance across the full product development lifecycle, supporting multidisciplinary teams in a technology-driven environment. You will interpret global regulations including ISO 13485, ISO 9001, and FDA 21 CFR 820, ensuring compliance while enabling innovation. The position is embedded in project work, offering real-time input on regulatory strategy and contributing to quality management systems across medical and non-medical sectors.

Newton Colmore Cambridge, United Kingdom
Hybrid Permanent
Smith & Nephew logo

Senior Regulatory Affairs Specialist

This role involves managing regulatory compliance for advanced wound care medical devices throughout their lifecycle, including preparing global regulatory submissions, guiding product development teams, and liaising with regulatory authorities. The specialist ensures adherence to standards such as ISO 13485, FDA 21 CFR Part 820, cGMP, and cGDP, while reviewing product documentation and supporting continuous improvement. Based in Hull, the position operates within a collaborative, global team environment focused on bringing innovative healthcare products to market.

Smith & Nephew United Kingdom
Hybrid Permanent

Senior Regulatory Affairs Specialist UK and Ireland

This role involves leading regulatory strategy and compliance for medicinal products, medical devices, and cosmetics in the UK and Ireland. The specialist will manage submissions, support product launches, ensure compliance with MHRA and HPRA, and maintain regulatory documentation. It requires strong post-Brexit regulatory knowledge and collaboration with global teams.

GI Group Euston, London, NW1 2EA, United Kingdom
Hybrid Contract
Top hirers

Companies hiring regulatory affairs specialists

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Hiring locations

Where this role is hiring

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

Cambridge

Location
2 open

London

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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