Regulatory Affairs Associate / Compliance Officer (AWDO-P15285) in Henley-on-Thames)

AWD online; Henley-on-Thames; Sur place; GBP 32 000 - 39 000; Plein temps

Avantages offerts par ce poste

BUPA

Pension

Staff discount at clinics

Golf

Gym vouchers

21 days’ holiday

Résumé du poste

Healthium Clinics is seeking a Regulatory Affairs Associate / Compliance Officer to bring regulatory rigour to our private medical clinic. You will support market access, quality systems and governance across healthcare and technology projects, ensuring evidence, registrations and controls are prepared for scrutiny.

The role requires clear communication, careful judgement and strong documentation to align patient care, innovation and high standards within a dynamic environment.

Qualifications

• Degree or qualification in regulatory affairs, quality assurance or related field.
• Experience in healthcare, clinical research, medical devices or digital health.
• Experience handling policies, SOPs, risk assessments and quality records.
• Ability to coordinate evidence across departments and manage multiple deadlines.
• Familiarity with regulatory lifecycle documentation and MHRA registration.
• Experience supporting internal or external audits.
• Strong understanding of regulated environments and data protection.
• Excellent organizational and communication skills.

Responsabilités

• Translate procurement requirements into evidence packs and deadlines.
• Support Quality Management System maintenance, policies and forms.
• Prepare regulatory and technical documentation, registrations and lifecycle evidence.
• Support governance, CQC readiness, inspections, and project reviews.
• Maintain risk assessments and assist audits; track actions.
• Maintain data protection and information governance controls.
• Review MHRA, CQC, NHS guidance; summarize implications.
• Liaise with regulators, clients, manufacturers and consultants.

Connaissances

Regulatory affairs

Quality assurance

Healthcare

Clinical research

Documentation control

Data protection

Formation

Relevant degree or professional qualification in regulatory affairs

Outils

MHRA device registration

GxP documentation tools

Description du poste

Regulatory Affairs Associate / Compliance Officer

Bring regulatory rigour to an ambitious healthcare environment where innovation, patient care and high standards go hand in hand. This opportunity suits someone who enjoys turning complex requirements into clear, practical compliance.

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

SALARY: starting at £35,000 per annum + Benefits

LOCATION: Henley-on-Thames, Oxfordshire

JOB TYPE: Full-Time, Permanent

JOB OVERVIEW

This is an opportunity to help shape how high standards, innovation and safe patient care come together across varied healthcare and technology activity.

As a Regulatory Affairs Associate / Compliance Officer you’ll support market access, quality systems and governance, working collaboratively with clinical, technical and commercial colleagues.

The Regulatory Affairs Associate / Compliance Officer will help keep evidence, registrations and controls ready for scrutiny while supporting practical progress. In this Regulatory Affairs Associate / Compliance Officer position, careful judgement, curiosity and clear communication will matter just as much as strong documentation.

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

• Market Access and Tenders: Translate procurement, commissioner and client requirements into evidence checklists, actions, owners and deadlines, and coordinate compliant evidence packs
• Quality Management System: Support the development and maintenance of the Quality Management System, including policies, SOPs, Work Instructions, forms, templates and quality records
• Regulatory and Technical Documentation: Monitor applicable requirements and prepare, coordinate and 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 developments and guidance from bodies including the MHRA, CQC, NHS organisations, NICE and ICO, summarising implications and supporting agreed changes
• Records and Stakeholder Liaison: Maintain accurate controlled compliance records and liaise professionally 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
• Previous experience within 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 and maintaining accurate compliance records and trackers
• Experience coordinating evidence across departments or subject‑matter experts while managing multiple workstreams or deadlines
• Familiarity with software medical‑device lifecycle documentation and experience of MHRA device registration
• Experience supporting internal or external audits
• Strong understanding of regulated environments, quality‑management principles, controlled documentation, data protection and confidentiality
• Working knowledge, where relevant, of UK Medical Devices Regulations 2002, MHRA requirements, ISO 13485, ISO 14971, IEC 62304, UK GDPR, Data Protection Act 2018, NHS information governance, CQC requirements, ISO 15189, NICE processes, EU MDR and US FDA requirements
• Strong organisational, analytical, document‑control and communication skills, with the ability to identify gaps, translate requirements into practical actions, work independently and elevate appropriately

DESIRABLE

• Direct experience supporting market access, healthcare tenders, procurement submissions, commissioner assurance or client due diligence
• Practical familiarity with CQC requirements and inspection preparation
• 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