Regulatory Affairs Associate / Compliance Officer

Healthium Clinics; Henley-on-Thames; On-site; GBP 32,000 - 38,000; Full time

Benefits offered by this job

BUPA

Pension

Staff discount at company clinics

Golf

Gym vouchers

21 days holiday, rising by 1 day each

Birthday day off

Job summary

Healthium Clinics is seeking a Regulatory Affairs Associate / Compliance Officer to join our team in Henley-on-Thames. The role focuses on turning complex regulatory requirements into practical actions across governance, clinical services and lifecycle documentation.

You will connect clinical, technical and commercial teams to ensure patient safety, data protection and confidential handling of information while supporting audits, tenders and market access.

Qualifications

• Essential: Relevant degree or professional qualification in regulatory affairs, quality assurance, healthcare, life sciences, clinical research or related discipline.
• Essential: Experience in healthcare, clinical research, medical devices or digital health, including preparing, reviewing or maintaining regulated documentation.
• Essential: Experience with policies, SOPs, risk assessments or quality records, and solid document-control knowledge.
• Essential: Ability to interpret regulatory, contractual and procedural requirements and turn gaps into practical actions.
• Essential: Experience coordinating evidence across teams while managing priorities.
• Essential: Understanding of data protection, confidentiality and compliance records.
• Essential: Strong organisational, analytical and communication skills with careful escalation.

Responsibilities

• Translate procurement and client requirements into evidence checklists and deadlines, and coordinate evidence packs.
• Support the Quality Management System, including policies, SOPs, templates and quality records.
• Maintain medical-device regulatory and technical documentation, registrations and lifecycle evidence.
• Support governance, inspections, and readiness for new clinical services and projects.
• Maintain risk assessments and registers, and track corrective or improvement actions.
• Maintain controls for confidential information and coordinate data-protection and cybersecurity evidence.
• Summarise regulatory guidance from MHRA, CQC, NHS, NICE and ICO and support changes.
• Liaise with regulators, commissioners, clients, manufacturers and consultants.

Skills

Regulatory affairs

Quality assurance

Document control

Regulatory interpretation

Project coordination

Data protection

Organisational skills

Analytical skills

Communication skills

Education

Relevant degree or professional qualification

Job description

Regulatory Affairs Associate / Compliance Officer

Join Healthium Clinics and help turn healthcare innovation into safe, well-governed delivery. This varied opportunity suits someone who enjoys making complex regulatory requirements clear, practical and actionable.

If you ve also worked in the following roles, we d also like to hear from you: Quality and Compliance Officer, Regulatory Compliance Officer, Compliance Associate, Quality Assurance Officer, Regulatory Affairs Officer, Quality and Compliance Associate, Governance and Compliance Officer, Regulatory Coordinator

Benefits include BUPA, birthday leave, staff discounts and gym vouchers.

SALARY: £32,000 - £38,000 per annum + Benefits

LOCATION: Henley-on-Thames, Oxfordshire

JOB TYPE: Full-Time, Permanent

JOB OVERVIEW

This is a chance to work where patient care, innovation and regulatory rigour meet, helping services progress with the right evidence and safeguards.

As a Regulatory Affairs Associate / Compliance Officer you ll support Healthium Clinics and Accellerate, connecting clinical, technical and commercial teams across healthcare, digital health and medical-device activity.

The Regulatory Affairs Associate / Compliance Officer will strengthen systems, tender readiness and governance while keeping quality, safety and confidentiality central.

The Regulatory Affairs Associate / Compliance Officer offers breadth, visible responsibility and the chance to make compliance an enabler of healthcare.

ABOUT US

Healthium Clinics is a private medical clinic specialising in the latest anti-aging and medical treatments designed to improve your health and wellbeing. Based in the elegant Badgemore Park, our luxurious treatment rooms have ample private parking and a discrete entrance, with appointments to suit your busy schedule. Our experienced and qualified medically led team work closely with you to achieve great results.

DUTIES

Your duties as the Regulatory Affairs Associate / Compliance Officer include:

• Market Access and Tenders: Translate procurement, commissioner and client requirements into evidence checklists, actions and deadlines, and coordinate evidence packs
• Quality Management System: Support the Quality Management System, including policies, SOPs, Work Instructions, templates and quality records
• Regulatory and Technical Documentation: Maintain medical-device regulatory and technical documentation, registrations and lifecycle evidence
• Clinical Governance and CQC: Support healthcare governance, CQC compliance, inspections, reviews and readiness for new clinical services and projects
• Risk Management and Audits: Maintain risk assessments and registers, support internal and external audits, record findings and track corrective or improvement actions
• Information Governance and Security: Maintain appropriate controls for confidential information and coordinate data-protection, information-governance and cybersecurity evidence
• Regulatory Monitoring: Review relevant guidance from the MHRA, CQC, NHS organisations, NICE and ICO, summarising implications and supporting agreed changes
• Records and Stakeholder Liaison: Maintain controlled compliance records and liaise with regulators, commissioners, clients, manufacturers, suppliers and consultants

CANDIDATE REQUIREMENTS

ESSENTIAL

• Relevant degree, professional qualification or equivalent experience in regulatory affairs, quality assurance, healthcare, life sciences, clinical research or a related discipline
• Experience in healthcare, clinical research, medical devices or digital health, including preparing, reviewing or maintaining regulated documentation
• Experience working with policies, SOPs, Work Instructions, risk assessments or quality records, with sound document-control and quality-management knowledge
• Ability to interpret regulatory, contractual and procedural requirements, identify gaps and turn them into practical actions
• Experience coordinating evidence across teams or subject-matter experts while managing competing priorities
• Good understanding of data protection, confidentiality and accurate compliance records
• Strong organisational, analytical and communication skills, with close attention to accuracy and appropriate escalation

DESIRABLE

• Familiarity with software medical-device lifecycle documentation and MHRA device registration
• Experience supporting internal or external audits
• Direct experience supporting market access, healthcare tenders, procurement submissions, commissioner assurance or client due diligence
• Practical familiarity with CQC requirements and inspection preparation
• Working knowledge of relevant frameworks or standards such as UK Medical Devices Regulations 2002, ISO 13485, ISO 14971, IEC 62304, UK GDPR, NHS information governance, ISO 15189, NICE processes, EU MDR or US FDA requirements
• Experience supporting regulatory evidence across different markets, businesses, clients or projects

BENEFITS

Joining Healthium Clinics means becoming part of an award-winning, forward-thinking healthcare organisation that is continuing to grow, innovate and expand its services. We are committed to investing in our people through structured onboarding, practical training and ongoing professional development, giving employees the opportunity to strengthen their expertise, take ownership of their work and progress within the organisation.

• BUPA
• Pension
• Staff discount at company clinics
• Golf
• Gym vouchers
• 21 days holiday, rising by 1 day each year to a maximum of 25 days, plus bank holidays
• Birthday day off

JOB REF: AWDO-P15285

This job is being advertised by AWD online on behalf of Healthium Clinics