453 Regulatory Specialist jobs in the United Kingdom

Regulatory Affairs Specialist (Pharma)

Circa 50k DOE

Full time ON-SITE. No Hybrid/Remote.

We are seeking an experienced Regulatory Affairs Specialist to join a growing pharmaceutical business and play a key role in ensuring compliance across development, manufacturing, and commercialisation activities. This role will focus on regulatory submissions, product registrations, and maintaining compliance with evolving MHRA, EMA, and ICH requirements.

You'll be responsible for preparing and submitting marketing authorisations, variations, and post-approval documentation, while also reviewing labelling and packaging to ensure regulatory accuracy. Acting as a key liaison with health authorities, you'll advise on regulatory strategy and support inspections, surveillance, and cross-functional compliance initiatives.

We're looking for someone with 5+ years of experience in pharmaceutical regulatory affairs, strong knowledge of global regulatory frameworks, and hands-on experience with eCTD and related document management tools. Excellent communication skills and the ability to work across teams are essential.
If you're keen to apply your expertise in a cooperative, fast-moving environment, this is a fantastic opportunity to make an impact on the successful delivery of pharmaceutical products to market.

Job Title: Regulatory Associate – Medical Devices

Location: West London/ Berkshire (Hybrid or On-site, depending on candidate location)

Employment Type: Full-Time

Are you looking to advance your career in Regulatory Affairs within a fast-paced and impactful medical device environment? We’re hiring a Regulatory Associate to join a highly collaborative RA/QA team and play a central role in global product compliance and regulatory strategy execution.

This is an exciting opportunity for someone with strong knowledge of the Medical Device Directive (93/42/EEC), EU MDR (2017/745), and ISO 13485, who thrives on autonomy, ownership, and making a real contribution to patient safety and product success.

Key Responsibilities

• Prepare and maintain global regulatory submissions and renewal
• Support external distributors, authorised reps, and internal teams on regulatory matters
• Compile and maintain MDR-compliant Technical Files and related documentation
• Lead the transition of existing MDD Technical Files to MDR format
• Manage post-market surveillance activities and clinical evaluation maintenance
• Conduct and support complaint trend analysis and ensure accurate reporting
• Monitor changes in global regulatory frameworks and advise management accordingly
• Participate in external audits (e.g. Notified Body) and host internal audits
• Review and approve product, labelling, and process changes for regulatory impact
• Ensure full regulatory compliance in EU, US, and other territories as required
• Liaise with Notified Bodies and coordinate Technical File audits

Candidate Profile

• Degree (2:1 or above) in a scientific or engineering discipline
• Proven experience working with Medical Devices under 93/42/EEC and MDR 2017/745
• Strong understanding of CE Marking, ISO 13485, ISO 14971, and GMP
• Familiar with medical device labelling (ISO 15223) and Essential Requirements Checklists
• Experience liaising with Notified Bodies and supporting audits
• Confident in authoring and maintaining Declarations of Conformity and Technical Files
• Highly organised, hands-on, and commercially astute
• Excellent communication, analytical, and problem-solving skills
• Ability to work independently and collaboratively in cross-functional teams

Why Apply?

You’ll be joining a passionate team that values quality, innovation, and continuous improvement. This role offers a unique opportunity to shape compliance processes and directly impact global patient access to life-enhancing medical devices.

To apply, please submit your CV and a short cover note outlining your suitability. For a confidential discussion about the role, feel free to get in touch directly.

Job Title:

Design Control and Risk Management Compliance Engineer

Location:

Cambridge, UK

Department:

Drug Product Design and Development (DPDD)

Reports To:

Design Control Lead

Position Summary

We are looking for a Design Control and Risk Management Compliance Engineer to join our Drug Product Design and Development team in Cambridge, UK. The role provides subject matter expertise in design control and risk management for medical device and drug-device combination product development throughout the product lifecycle. The successful candidate will ensure compliance with quality and regulatory requirements, support design validation, and collaborate closely with internal teams, external design partners, and manufacturing organizations.

Key Responsibilities

• Lead and oversee design control and risk management activities for medical device and combination product development programs.
• Ensure design control and risk management documentation is authored, approved, and maintained in line with global regulatory and quality standards.
• Provide support and guidance to cross-functional teams, external design companies, and manufacturing partners.
• Contribute to design validation activities, including use-related risk assessments.
• Support the preparation of regulatory submission data and content.
• Assist with internal and external audits of Quality Management Systems.
• Ensure all activities are compliant with applicable regulations, standards, and company processes.

Education, Skills, and Experience

Essential Requirements

• BSc or MSc in a relevant science or engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering, or related).
• Minimum 5 years’ experience in the medical device and/or pharmaceutical combination product industry .
• Strong experience in design control and risk management for medical devices or combination products.
• In-depth knowledge of regulatory standards including:
• ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and EU MDR.
• Understanding of Good Manufacturing Practices (GMP) .
• Excellent communication skills (oral, written, and presentation).
• Strong attention to detail, organizational skills, and ability to manage multiple projects.
• Ability to work independently as well as in cross-functional teams.
• Valid driving license and willingness to travel when required.

Desirable Skills

• Familiarity with Human Factors / Usability Engineering (EN 62366).
• Knowledge of device assembly and related manufacturing processes.
• Experience with standards such as EN 60601 (electrical safety) and EN 62304 (software).
• Experience supporting internal and external audits.

What We Offer

• Opportunity to work on innovative drug-device combination products .
• Collaborative and supportive team environment.
• Competitive salary and benefits package.
• Professional growth and development opportunities.

Regulatory Specialist – Telecommunications

Salary: Circa £85,000 + benefits

Location: UK-based (relocation support available)

This is a rare chance to step into a high-profile role at the heart of a dynamic telecoms business, based in one of the world’s most attractive offshore business hubs - a financial capital with a thriving telecoms sector, excellent quality of life, and a close-knit professional community.

As Regulatory Specialist, you’ll be involved in everything the business touches - from strategic policy and licence compliance to competition law, spectrum applications, and commercial negotiations. You’ll work closely with the Head of Legal & Regulatory, local CEOs, and the Group CEO, shaping decisions that impact operations across multiple jurisdictions.

You’ll need the gravitas to hold your own with senior stakeholders, the confidence to find answers even when you don’t know them immediately, and the ability to turn your mind quickly to any challenge that arises. This is not a narrow, process-only role - you’ll be a stretched and always learning. You will be trusted to deliver pragmatic, commercially aware advice in a fast-moving environment.

In this role, you will:

• Lead on varied, high-impact regulatory matters across a multi-jurisdictional telecoms group
• Build strong relationships with regulators and other key stakeholders, navigating sometimes challenging dynamics
• Shape and implement regulatory policy and strategy that aligns with commercial objectives
• Engage with issues as diverse as interconnection, competition regulation, market challenges (including satellite operators), and emerging technologies
• Work closely with a small, highly capable legal & regulatory team across several jurisdictions

What we’re looking for:

• At least 5 years’ experience in telecoms regulation or another network industry (energy, water, etc.) - experience in large corporate environments is welcome if you’ve had broad exposure to multiple aspects of regulation
• Strong stakeholder management skills and the confidence to operate at executive level
• Proven ability to work independently, prioritise effectively, and solve problems pragmatically
• UK citizenship or the right to work in the UK

This is a fantastic career move for a regulatory expert seeking variety, influence, and the opportunity to shape strategy across diverse markets - all while enjoying the benefits of working in a unique, vibrant location.

Apply now to learn more about this fantastic opportunity.

This is a fantastic opportunity for a Senior Principal Regulatory Specialist to join an established, global Medical Device company based near the South Coast in Hampshire. The business operates with hybrid flexibility of 3 days onsite/2 remote, and flexi hours too! The position is offering a six-figure salary with amazing benefits including 15% bonus, healthy pension (5% personal, 9% company contr.

What does 'family business' mean to you?

For some, it's code for small, for others it is a collaborative and friendly space.

The truth - it's usually both.

Family, small to midsized pharmaceutical companies look after their staff. You become part of their community, their culture, and the way they do things.

In our experience, staff at family run SMEs experience longer levels of employment than at large global corporations, and are often compensated well over time for their rewards.

Which is why, I am delighted to be representing a leading (family run) pharmaceutical manufacturing organisation based near Watford in the UK.

This amazing company are going through a great transformation that should ensure the company's future for generations to come, and as part of that they are looking for reliable, professional and hard working Regulatory Affairs professionals.

As part of this expansion, our client is looking for someone with 5+ years experience in Pharmaceutical Regulatory Affairs (ideally in a similar style of company, but they are open to people from all different pharmaceutical organisations).

You need to have a hard working attitude, good attention to detail, and you need to be able to work well with your team. Your experience in eCTD manager and document management tools will be valued, and you will need knowledge of global Regulatory requirements and guidelines (MHRA, EMA and ICH).

This is a site based role near Watford (5 days per week) and would suit someone looking for a company they can grow with, and build with, and that will give them huge career tragectory in a culture that is supportive and dynamic.

Interested? Apply Now!