Regulatory Affairs Associate / Compliance Officer

Healthium Clinics; Lower Assendon; 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, rising to 25 + bank

Birthday day off

Résumé du poste

Healthium Clinics seeks a Regulatory Affairs Associate / Compliance Officer to bring regulatory rigour to a healthcare environment blending innovation and patient care. You will support market access, quality systems and governance across clinical, technical and commercial teams.

The role involves maintaining evidence, registrations and controls for scrutiny, with clear communication and careful judgement as essential attributes.

Qualifications

• Regulatory affairs, quality assurance in healthcare, life sciences knowledge.
• Experience maintaining regulated documentation and quality records.
• Familiarity with risk assessments, SOPs and policy documents.
• Experience coordinating evidence across departments and managing multiple workstreams.
• Knowledge of MHRA device registration and lifecycle documentation.
• Audits and inspections support experience.

Responsabilités

• Market Access and regulatory evidence coordination across teams.
• Support development and maintenance of Quality Management System and records.
• Prepare and maintain regulatory/technical documentation and registrations.
• Support governance, CQC compliance, inspections and readiness for new services.
• Maintain risk assessments and support internal/external audits and actions.
• Manage information governance, data protection and cybersecurity evidence.
• Monitor MHRA/NHS/NICE guidance and summarise implications.
• Maintain controlled compliance records and liaise with regulators and clients.

Connaissances

Regulatory affairs knowledge

Quality management

Audits & compliance

Documentation control

Cross-functional collaboration

Formation

Relevant degree or professional qualification

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 esc

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