175 Regulatory Documentation jobs in the United Kingdom

Job Description
CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women's and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at

Responsibilities
At CooperSurgical we are currently looking to recruit a
Regulatory Affairs Specialist
for an 18-month contract to cover maternity leave. You will be part of the global regulatory team, but primarily work with the UK RA based team. For this position you can be based in UK or EMEA and have an opportunity to work from home, remotely. This role will be reporting to the RA Manager based in UK.

Position
In the role of RA Specialist, you will be responsible for submissions globally but primary focusing on MEA and LATAM. You have strong experience with global product registration and re-registration and adept at liaising with the right people to collect and gather the relevant documentation and files. You will be responsible for completing annual renewals and following up on deadlines and tasks, to meet submission timelines. Preferable you have worked with single use sterilized products and electrical, electronic devices, and be familiar with the appropriate standards and regulations.

As a person you thrive in a dynamic and busy environment which provides you with an opportunity to use your planning and prioritization skills to meet deadlines and progress registration projects. You will work closely together with other RA professionals and cross functional stakeholders in this international organization.

The position as RA Specialist is vital for the success and growth of CooperSurgical.

Your Key Responsibilities

• Lead regulatory activities, reviewing, maintaining, and submitting files and legalized documentation
• Facilitate collection of data for international registrations
• Complete administrative RA tasks
• Monitor for any change in META & LATAM medical device regulations
• Liaise with stakeholders globally

Qualifications

• MSc in relevant field Engineer, Bio Science, Technical or alike
• • 2-3 years of experience from a similar role -preferable
• Global submission experience
• Structured and systematic work ethic
• Strong communication and problem-solving skills
• Proficient level in MS office
• Fluent English (spoken and written) is mandatory
• A can-do attitude and proactive approach

About Us

Native Formulas Limited is a UK-based cosmetic safety consultancy dedicated to helping beauty businesses and cosmetic brands comply with UK and EU cosmetic regulations.

We provide expert regulatory services including Cosmetic Product Safety Reports (CPSRs), Product Information Files (PIFs), portal submissions, labelling and claims reviews, and post-market compliance support.

Our mission is to make cosmetic compliance accessible, transparent, and reliable for brands of all sizes.

Role Overview

We are seeking a Regulatory Affairs Officer with a postgraduate qualification in cosmetic science or a related discipline, who is passionate about cosmetic regulatory compliance. This role involves preparing safety documentation, reviewing labelling and claims, and assisting clients to ensure their products meet UK and EU legal requirements.

Key Responsibilities

Prepare Cosmetic Product Safety Reports (CPSRs) and compile Product Information Files (PIFs).

Review ingredient lists, INCI names, packaging, and labelling for compliance with UK and EU cosmetic regulations.

Assist with regulatory submissions to the UK Submit Cosmetic Product Notification (SCPN) portal and EU Cosmetic Product Notification Portal (CPNP).

Validate product claims and ensure correct warnings and mandatory statements are included.

Monitor global cosmetic regulatory changes and update internal procedures and client guidance.

Support post-market compliance activities including adverse event reporting and regulatory responses.

Provide scientific and regulatory advice to clients and colleagues.

Candidate Profile

Master's degree in Cosmetic Science, Pharmaceutical Sciences, Chemistry, Toxicology, or related field.

Strong knowledge of UK and EU Cosmetic Regulations (EC 1223/2009 and UK Cosmetics Regulation 2019).

Familiarity with PIFs, CPSRs, labelling requirements, and regulatory submissions.

Excellent organisational skills and attention to detail.

Strong written and verbal communication skills, with the ability to work independently and with clients.

Details & Benefits

Type: Full-time, permanent position.

Location: Bournemouth

Salary: Competitive.

Culture: Supportive, specialist consultancy environment focused on quality, compliance, and client success.

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.

Role - Regulatory Affairs Manager

Duration - 12 Months

Location - Remote

Outside IR35

The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RAM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Responsibilities:

• Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
• Submission delivery strategy of all dossiers and all application types per market and /or region.
• Review of documents (e.g. response documents, study protocols, PSRs, etc.).
• Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
• Use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
• Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and with experience, increasingly more complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Coordinate the input, maintenance and revision in the Planit project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
• Identify regulatory risks and propose mitigations to Lead RPM and cross functional teams.
• Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs and/or alliance partners where relevant.
• Provide coaching, mentoring and knowledge sharing within the RAM skill group.
• Contribute to process improvement.

Minimum Requirements –Education and Experience

• Relevant University Degree in Science or related discipline
• Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
• Thorough knowledge of the drug development process
• Managed regulatory deliverables at the project level
• Strong project management skills
• Leadership skills, including experience leading multi-disciplinary project teams

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements

Job title: Regulatory Affairs Administrator

Reports to: Senior Regulatory Affairs Specialist

Location: Onsite role based at our Manchester HQ located at Manchester Science Park, M15 6SH

Contract Type: Full-time, Permanent

Salary & Benefits: Competitive Salary + Benefits Package

About Yourgene Health:

Yourgene Health is a leading integrated technologies and services business, enabling the delivery of genomic medicine. The group works in partnership with global leaders in DNA technology to advance diagnostic science. Our mission to enable scientific advances to positively impact human health remains at the core of our focus. It drives and motivates us to develop class leading products and services to meet our customers’ needs.

Yourgene primarily develops, manufactures, and commercialises simple and accurate molecular diagnostic solutions, for reproductive health, precision medicine and infectious diseases. We have a comprehensive offering of non-invasive prenatal tests (NIPT) NGS workflows that have been built with labs in mind, and clinical prenatal screening services. The IONA® test was the pioneer, the first to market as an IVD product, changing the NIPT screening landscape back in 2015. Continuing to build on our expertise in cell-free DNA, our next generation size selection Ranger® Technology uses machine vision for superior precision. With multiple platforms for a range of clinical and research cfDNA sample preparation applications including NIPT, liquid biopsy, gene synthesis and long fragment recovery.

In addition, we offer a portfolio of screening products in reproductive health, precision medicine and infectious disease including screening assays for cystic fibrosis and DPYD genotyping to prevent chemotoxicity.

Yourgene Genomic Services provides a range of genetic analysis services for our clinical, research and pharma customers to support partners with DNA extractions, biobanking, genotyping, arrays and sequencing workflows (WES and WGS). Yourgene Genomic Services offers a Non-Invasive Prenatal Testing (NIPT) Service, enabling clinics to run their own NIPT service for pregnant women with our prenatal screening tests and service laboratory based in Manchester.

Yourgene Health is part of the Novacyt group of companies and is headquartered in Manchester, UK with facilities in Singapore and Canada.

Our Culture:

Yourgene is a growing, vibrant and exciting place to work, we are looking for committed driven individuals to be part of our next growth journey. Our culture is described by our employee's as collegiate, friendly, professional, innovative, open and fast paced. We have many social and wellbeing initiatives run by our Nova Social and Charity Huddle that keep our sense of community and togetherness alive. At Yourgene we focus on putting values led programmes in place to ensure that we can attract, retain and develop our people. We want our people to have a career with Yourgene and we ensure that they are recognised and rewarded for their achievements and commitment, everyone plays a critical role in our growth journey.

Description of role:

Yourgene Health, part of the Novacyt Group, are recruiting for a Regulatory Affairs Administrator at Yourgene Health is responsible for maintaining the Post Market Surveillance activities in compliance with the IVD Regulation (IVDR) and any other relevant global markets. This role will help to support the effective monitoring of the organisation’s in vitro diagnostic devices, allowing Yourgene Health to remain in compliance with the IVD Regulation by routinely reporting on the safety and effectiveness of devices currently on the market.

Key areas of responsibility:

• The maintenance of the Post Market Surveillance schedule in accordance with the requirements of the IVD Regulation (2017/746/EC), TG(MD)R 2002, CMDR SOR-98-282 and The Medical Devices (Post-Market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368).
• The completion of Post Market Surveillance activities on an annual basis and in accordance with the schedule, including:
• Conducting vigilance searches using keyword search terms or product codes of national/international incidents databases such as MHRA Medical Device Alerts and Field Safety Notices (UK), Database for Recalls, Product Alerts and Product Corrections (DRAC) (Australia), Health Canada Recalls and Safety Alerts, Swissmedic (Switzerland), FDA Medical Device Recalls and MAUDE Database (USA), FDA Medical Devices Recalls Database (USA), EUDAMED Vigilance Database and HSA Online Safety, Compliance Application and Registration (OSCAR) System (Singapore).
• Conducting literature searches using scientific databases such as PubMed and the Cochrane Library databases to identify scientific literature pertinent to the device and evaluate its performance in the market.
• Collating the post market surveillance data inputs from all functions into a final report format to either present as a Post Market Surveillance Report, Periodic Safety Update Report or Post Market Performance Follow Up Report.
• Analysing data to form an overall conclusion of the post market activities, whether any further actions are required, whether there are any findings of significance that may affect the risk of the device and/or whether the device continues to perform and is safe and effective in the market.
• Maintain specialist personal knowledge of the regulatory requirements within the operational global markets and disseminate information of relevance within the Regulatory Affairs function.
• Monitor the regulatory environment within the operational global markets, assessing the impact of any new of changing regulations to internal regulatory processes.
• As required, participate in medical device reporting, product recalls and withdrawals.
• Perform all duties in compliance with the Quality Management System, IVDR, ISO 13485, ISO 9001 and any other identified regulatory requirements.
• As required, support any third party assessments.

Qualifications, Skills and Abilities:

• Degree in a life science subject or medical field (Molecular Biology, Genetics, Biotechnology, Biochemistry or similar).
• Minimum of 1-3 years of relevant experience with in-vitro diagnostic devices (preferred) or medical devices industry.
• Experience of working within the Regulatory Affairs remit, knowledge of international regulations is highly desirable.
• Knowledge of working to a QMS, ISO 13485, ISO 9001 and IVDR.
• Excellent organisational and time management skills with an ability to work to tight timelines.
• High level of attention to detail.
• A positive attitude.
• Demonstrate the ability to effectively collaborate and work as part of a team.
• Proficient in the use of IT, including Microsoft Office suite.
• Excellent communication skills when liaising within the company and with external customers.

Closing Date:

Sunday 16th November, 2025

Equal opportunities:

Yourgene Health and the Novacyt Group of companies provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Yourgene Health and the Novacyt Group of companies is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Yourgene Health and Novacyt Group employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Yourgene Health and the Novacyt Group of companies. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

ARC's purpose is to expedite access to precision medicine clinical trials for patients globally. We fulfil our purpose through our dedicated team of experts with unparalleled domain knowledge, and the important relationships we have developed with our global clients.

We are a Belfast-based Clinical Research Organisation that specialises in delivering compliance excellence for companies in the precision medicine sector. We support many of the world's leading pharmaceutical R&D companies in implementing unapproved diagnostics in their clinical development programmes for patient selection or stratification, working as a strategic and integrated expert partner, taking full sponsor ownership of the IVD study being conducted in parallel with our clients' IND/IMP trial.

ARC's team of experts cover IVD regulatory compliance, study design and approvals, quality assurance including vendor due diligence and management along with a team of clinical research experts who manage the IVD study, ensuring it is conducted in compliance with local and global GCP, and that the biomarker data is robust and reliable.

To further support our growing client base and to expedite patient access to life-saving experimental medicines, ARC has developed and launched our SaaS platform, ARC360. ARC360 is transforming how organisations access regulatory intelligence and tailor study-specific information for using in vitro diagnostics to select and manage patients in IND trials. Powered by cutting-edge technologies and supported by a team of regulatory, quality, and clinical operations experts, ARC360 is designed to accelerate the initiation of complex clinical trials.

Job Description

To be an integral member and significant contributor to project team(s) in the development and delivery of global compliance solutions to client companies, ensuring that client objectives are met and exceeded at all times. This will require the utilisation of a platinum standard approach to regulatory research, internal and external stakeholder satisfaction as well as an innate work ethic and attention to detail that is aligned with the company’s core values.

• Support the work of the company and project teams in the provision of specialised regulatory and quality assurance expertise to client companies, ensuring client expectations and interests are met.
• Research and prepare elements of regulatory submission documents on behalf of client companies, including but not limited to study risk determination requests, IDE submissions, 510(k), PMA, CE Technical Files and Design Dossiers, PMDA Briefing Documents and Submissions etc.
• Assist wider team in understanding the regulatory requirements for an investigational device in the set-up, management & conduct of IVD performance studies worldwide.
• Manage and keep up to date information relating to regulatory requirements for IVD performance studies and maintain the company’s web-based clinical trial planning tool.
• Conduct gap analyses on behalf of client companies and prepare associated reports
• Contribute to the preparation of global guidance documents and white papers.
• Contribute to the preparation of other regulatory documents on behalf of client companies (e.g., Performance Evaluation Plans/Reports, Investigator Brochures, etc).
• As required, take advantage of professional networking opportunities to promote the company and its services to appropriate parties.
• Undertake continuing professional development activity to ensure awareness of current quality and regulatory standards.
• Contribute to ARC company culture initiatives to maintain a positive and engaging workforce.
• Any other duties, within reason and capability, as determined by company management.

Essential Criteria

• Engineering or Scientific honours degree or equivalent (10+ years) relevant industry experience
• 5+ years’ experience of working in a medical device/IVD manufacturing or regulatory environment
• Experience with IVD/CDx design and development, from feasibility to approval
• Knowledge of regulations in key global markets as they pertain to IVD and/or CDx devices (e.g. EU/US)
• Experience of leading global regulatory submissions (e.g. EU/FDA)
• Experience developing and maintaining technical documentation (IVDD/IVDR) or design history file documentation (FDA)
• Experience developing global regulatory strategies for IVD devices

“We are an equal opportunity employer; applications are welcome from all and appointment will be made on the basis of merit.”

Join a leading innovator in the chemical sector, driving compliance and sustainability across global markets. We’re seeking a detail-oriented Regulatory Affairs Specialist with a strong foundation in chemical regulations to ensure our products meet all legal and safety standards.

The Role

As a Regulatory Affairs Specialist , you will play a pivotal role in managing product registrations, preparing regulatory documentation, and maintaining compliance with national and international chemical legislation (REACH, CLP, SDS, etc.). You’ll collaborate with R&D, Quality, and Commercial teams to support new product introductions and ensure continuous regulatory alignment.

Key Responsibilities

• Prepare, review, and submit product registration dossiers and notifications.
• Maintain up-to-date knowledge of chemical regulations and compliance requirements.
• Support Safety Data Sheet (SDS) authoring and classification activities.
• Liaise with regulatory authorities and third-party consultants.
• Contribute to internal audits and compliance projects.
• Provide regulatory guidance for product development and market access.

The requirements

• Bachelor’s degree (or higher) in Chemistry, Toxicology, Environmental Science, or a related field.
• Minimum 2 years’ experience in regulatory affairs within the chemical, pharmaceutical, nutraceutical and/or food industries .
• Working knowledge of REACH, CLP, and GHS regulations.
• Strong analytical, organizational, and communication skills.
• Ability to manage multiple projects and deadlines effectively.

Join a leading innovator in the chemical sector, driving compliance and sustainability across global markets. We’re seeking a detail-oriented Regulatory Affairs Specialist with a strong foundation in chemical regulations to ensure our products meet all legal and safety standards.

The Role

As a Regulatory Affairs Specialist , you will play a pivotal role in managing product registrations, preparing regulatory documentation, and maintaining compliance with national and international chemical legislation (REACH, CLP, SDS, etc.). You’ll collaborate with R&D, Quality, and Commercial teams to support new product introductions and ensure continuous regulatory alignment.

Key Responsibilities

• Prepare, review, and submit product registration dossiers and notifications.
• Maintain up-to-date knowledge of chemical regulations and compliance requirements.
• Support Safety Data Sheet (SDS) authoring and classification activities.
• Liaise with regulatory authorities and third-party consultants.
• Contribute to internal audits and compliance projects.
• Provide regulatory guidance for product development and market access.

The requirements

• Bachelor’s degree (or higher) in Chemistry, Toxicology, Environmental Science, or a related field.
• Minimum 2 years’ experience in regulatory affairs within the chemical, pharmaceutical, nutraceutical and/or food industries .
• Working knowledge of REACH, CLP, and GHS regulations.
• Strong analytical, organizational, and communication skills.
• Ability to manage multiple projects and deadlines effectively.

Regulatory Manager (Permanent) – Medical Devices

Leicester (Hybrid) – Office-based culture with flexibility (approx. two days from home)

Applicants must have the right to work; sponsorship / future sponsorship cannot be supported.

This is an opportunity to step into a visible, commercially connected Regulatory role where you’ll shape market expansion for a leading UK manufacturer of Class IIb medical devices .

You’ll join a company with a diverse portfolio of consumer medical products sold through major high-street retailers and international partners. The business is privately owned, well-resourced, and operates with the spirit of an SME.

Due to steady growth, they are creating a new position to take the lead on global product registrations and drive market access across Asia, Africa, and other Rest-of-World regions .

You’ll also support ongoing MDR transition work alongside an experienced Senior Regulatory Manager.

The Opportunity

Visibility and Ownership:

Take responsibility for defining and executing global regulatory submissions while working closely with senior leadership.

Strategic Input:

Work with the commercial team to decide the most effective route to market — whether to register products via local distributors or retain legal manufacturer responsibility directly.

Market Expansion:

Lead regulatory submissions and product registrations worldwide, ensuring compliant and timely approvals across Rest-of-World territories.

Collaboration:

Partner with quality, manufacturing, and commercial teams to maintain compliance and enable new launches.

Career Growth:

Join at a time of expansion, with scope to progress towards the Head of Compliance role in the medium term.

Culture and Flexibility:

Enjoy an open, down-to-earth working environment with genuine flexibility.

How You’ll Make an Impact

• Lead regulatory submissions and product registrations across Asia, Africa, and other Rest-of-World markets.

• Advise on market entry strategy, helping assess regulatory complexity, cost, and timelines.

• Provide regulatory input for new product acquisitions, determining legal manufacturer and distributor responsibilities.

• Manage and support two Regulatory Associates.

• Contribute to MDR transition work where required.

• Collaborate across functions to ensure continued compliance and readiness for new product launches.

Who Will Thrive Here

• Experienced in medical device regulatory affairs , with multi-country registration experience .

• Commercially minded with the ability to balance compliance requirements with business goals.

• Skilled at building relationships and influencing cross-functional teams.

• Enjoys working in smaller, collaborative settings where responsibilities are broad and shared.

• Holds a scientific or technical degree (chemistry or related discipline preferred).

• Experience with sterile products or cosmetics is a plus, but medical devices expertise is key.

Who You’ll Be Joining

You’ll be part of a well-established UK manufacturer known for quality and innovation in medical devices and consumer health products.

With around 100 employees across two sites, the company combines the stability of a larger organisation with the agility and informality of a smaller team .

They’re strengthening their compliance frameworks and expanding into new international markets.

Collaboration, flexibility, and mutual support are at the heart of how they work.

Why This Role Stands Out

• Hybrid working – typically three days in the Leicester office.

• Supportive, people-focused culture where everyone contributes.

• Real career growth potential within a respected UK medical device company.

Apply today or contact