239 Compliance With Regulations jobs in the United Kingdom

• Develop, implement, and manage a comprehensive compliance program in line with financial regulations (e.g., AML, KYC, GDPR, FCA).
• Conduct regular risk assessments to identify potential compliance vulnerabilities and implement mitigation strategies.
• Oversee the creation and delivery of compliance training programs for all employees.
• Monitor regulatory changes and ensure timely updates to policies and procedures.
• Manage regulatory examinations and audits, serving as the primary point of contact with regulatory bodies.
• Investigate potential compliance breaches and implement corrective actions.
• Develop and maintain strong relationships with external legal counsel and regulatory authorities.
• Prepare and submit required regulatory reports accurately and on time.
• Lead and mentor the compliance team, fostering a culture of ethical conduct and regulatory awareness.

• Law degree or a related field, with specialized knowledge in financial regulations.
• Minimum of 8 years of experience in compliance, risk management, or legal roles within the financial services or fintech industry.
• In-depth knowledge of relevant regulations such as AML, KYC, MiFID II, GDPR, and others applicable to financial services.
• Proven experience in developing and implementing compliance programs.
• Strong analytical, problem-solving, and investigative skills.
• Excellent communication, interpersonal, and presentation skills.
• Demonstrated leadership experience with the ability to manage and motivate a team.
• Ability to work independently and manage multiple priorities in a remote setting.
• Relevant professional certifications (e.g., CAMS, CRCM) are a strong asset.

We are partnering with a global leader in transfusion and infectious disease diagnostics seeking a Regulatory Affairs Manager to join its Regulatory & Quality team. This is a pivotal role overseeing global product registrations and compliance activities across the product portfolio, ensuring regulatory excellence from development through to post-market.

Key Responsibilities:

Regulatory Leadership

• Lead regulatory strategy and execution for global product registrations, renewals, and submissions (EU IVDR, FDA BLA/510(k)/PMA, Health Canada, and rest-of-world)
• Ensure technical documentation and EU declarations of conformity are maintained and compliant with ISO 13485, IVDR, and FDA regulations
• Interpret evolving legislation and guide senior management and cross-functional teams on compliance strategy

Operational Oversight

• Oversee preparation, review, and submission of regulatory dossiers supporting new product approvals and post-market activities
• Manage assessments of product changes and coordinate notifications to regulatory agencies
• Serve as the company’s regulatory contact for competent authorities, business partners, and distributors

Team Management & Cross-Functional Collaboration

• Lead, mentor, and develop the Regulatory Affairs team, fostering accountability and technical excellence
• Collaborate with Quality, R&D, and Manufacturing to ensure alignment of regulatory objectives and operational delivery
• Contribute to the design and implementation of quality systems that support continuous improvement and compliance

Ideal Candidate

• Degree or advanced qualification in life sciences or regulatory affairs
• Extensive experience leading regulatory submissions (BLA, 510(k), PMA, CE-IVDR/IVDD) within diagnostics or medical devices
• Deep understanding of regulatory frameworks including ISO 13485, FDA CFR, and international medical device regulations
• Proven leadership experience managing regulatory teams and complex projects
• Skilled communicator with strong influencing and stakeholder management capabilities
• Fluent in English; additional languages beneficial

If you’re a strategic regulatory leader who thrives in a global, science-driven environment, and want to shape the compliance foundation for innovative diagnostics, this is an opportunity to make a lasting impact.

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

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.”

Job Title: Regulatory Affairs Consultant

Location: Maidenhead

Contract: 12 months / hybrid 3 days onsite

Hours: 37.5 per week

Rates: £50-60p/h

Job Description

SRG are looking for a regulatory affairs consultant to join a leading pharmaceutical company based in maidenhead. As part of this role, you will be Supporting lifecycle management of applicable products or submissions, management of paediatric investigation plans and clinical trial activities with the Medicines and Healthcare Products Regulatory Agency (MHRA).

Duties and Responsibilities

Overall responsibilities

With supervision and guidance from Line Manager;

• Acts as the primary Regulatory contact for identified portfolio.
• Develops robust regulatory strategies and timelines for those products throughout their lifecycle and provides regulatory information updates to cross functional team.
• Develops and maintains relationships with cross functional partners, as well as the Area Regulatory team to advocate the UK strategy objectives and timelines through the Area Regulatory Project Team.
• Serves as Health Authority liaison and interface for Health Authority meetings to obtain optimal outcomes for patients and company portfolio.
• Supports the business in planning for and execution of product launches, acquisitions and divestitures, as required.
• Regulatory intelligence and external landscape monitoring – provides regulatory impact assessment and establishes best practice

Main Accountabilities

• Supports Area and Brand teams as required to ensure local strategy is considered and that the key regulatory messaging is understood.

• Ensures submission and content of MHRA new and product lifecycle applications are made in accordance with appropriate timings and requirements

• Ensures appropriate and timely communication of regulatory and safety information as required by local regulation, company policies and procedures

• Keeps up to date with all appropriate Regulatory issues and operate as a ‘problem-solver’, to provide effective resolution of regulatory issues occurring within the UK, with an appreciation of business needs and priorities and will escalate to the Director, Regulatory Affairs as necessary.

• Builds business relationships with key internal stakeholders, including Europe region Regulatory Affairs, Medical Affairs, Market Access, Commercial and QA, as required to enable good cross-functional working.

• Stays abreast of all Regulatory intelligence updates and is proactive regarding implementation of necessary legislation/regulation changes.

Experience and Qualifications

• Life Sciences Degree or equivalent experience
• Varied experience within UK or EU Regulatory Affairs, including clinical trials, paediatric investigation plans, license lifecycle management
• Excellent communication skills, both verbal and written
• Effective influencing, tactical and presentation skills
• Effective project management experience
• Consultative and collaborative interpersonal style
• Excellent English language skills
• The ability to thrive in a changing environment and to re-prioritise workload to meet business needs.

Regulatory Affairs manager – Medical Devices

A new role in Regulatory Affairs has become available at an exciting medical devices organisation who have products undergoing clinical trials. The role focuses on FDA and UK/EU submissions

As an experienced Regulatory Affairs professional, you’ll manage and prepare regulatory submissions (e.g., variations, renewals, new market applications) and ensure compliance with U.S. (FDA) and European (EMA) regulations. Key responsibilities include strategic planning, cross-functional coordination with manufacturing, quality assurance, regulatory writing and document review, and liaising with health authorities.

The company has exciting medical device products currently undergoing clinical trials. Head office is based in Oxfordshire.

Key Responsibilities

• Submission Strategy:

Developing strategic plans for regulatory submissions, including variations, renewals, and new market applications.

• Document Preparation:

Writing, reviewing, and ensuring the accuracy and compliance of submission documents, such as Chemistry, Manufacturing, and Controls (CMC) data, study reports, and other regulatory materials.

• Regulatory Compliance:

Ensuring all submissions and regulatory activities meet the requirements of the FDA (U.S.) and European Medicines Agency (EMA).

• Cross-Functional Coordination:

Collaborating with internal teams (manufacturing, quality assurance, quality control, etc.) and external partners to gather necessary information for submissions.

• Authority Interaction:

Communicating with health authorities (e.g., FDA, EMA) regarding submissions, queries, and regulatory matters.

• Post-Approval Maintenance:

Managing ongoing regulatory activities such as post-approval variations, annual reports, and changes to product manufacturing.

Required Skills & Qualifications

• Regulatory Knowledge: In-depth understanding of FDA and EU regulatory requirements for pharmaceutical products or medical devices.

• Technical Skills: Proficiency in regulatory document management systems and MS Office applications.

• Communication: Strong written and verbal communication skills in English.

• Project Management: Ability to manage multiple projects, meet deadlines, and prioritize tasks effectively.

• Collaboration: A collaborative team player with cultural awareness and adaptability.

This is an exciting opportunity at a growing medical devices organisation. The facility is based in Oxfordshire and offers hybrid working opportunities.

We look forward to receiving your application.

CY Partners is acting as an Employment Business / Agency in relation to this vacancy.

Walker Cole are recruiting for a Regulatory Affairs Manager position for an early stage ATMP pharmaceutical business. This is an exciting opportunity for a junior professional to grow and develop within the ATMP space from a range of skills and experience within the team.

A Regulatory Manager will bring:

• Regulatory CMC experience at early-stage development in ATMP and/or biological products
• A drive and willingness to learn and grow within this space.
• Ability to work well within a team, cross functionally and independently

As a Regulatory Manager you will:

• Work within an expert team on Regulatory CMC
• Support in CMC gap analysis, write guidance document and IMAPs
• IMPD, IND submissions and pre-clinical activities.

Early-Stage // Development // Pre-clinical // Regulatory CMC // Regulatory Affairs // Biologics // ATMP // Advanced Therapy //

Walker Cole are recruiting for a Regulatory Affairs Manager position for an early stage ATMP pharmaceutical business. This is an exciting opportunity for a junior professional to grow and develop within the ATMP space from a range of skills and experience within the team.

A Regulatory Manager will bring:

• Regulatory CMC experience at early-stage development in ATMP and/or biological products
• A drive and willingness to learn and grow within this space.
• Ability to work well within a team, cross functionally and independently

As a Regulatory Manager you will:

• Work within an expert team on Regulatory CMC
• Support in CMC gap analysis, write guidance document and IMAPs
• IMPD, IND submissions and pre-clinical activities.

Early-Stage // Development // Pre-clinical // Regulatory CMC // Regulatory Affairs // Biologics // ATMP // Advanced Therapy //