At a Glance
- Tasks: Transform complex regulations into clear compliance actions in a dynamic healthcare setting.
- Company: Join Healthium Clinics, an innovative leader in healthcare and patient care.
- Benefits: Enjoy competitive salary, BUPA, pension, gym vouchers, and 21+ days holiday.
- Other info: Be part of a growing team with excellent career development opportunities.
- Why this job: Make a real impact on patient care while developing your skills in a supportive environment.
- Qualifications: Relevant degree or experience in regulatory affairs, quality assurance, or healthcare.
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.
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 position, careful judgement, curiosity and clear communication will matter just as much as strong documentation.
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 escalate 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
NO AGENCIES PLEASE
To be considered for this job vacancy, please submit your CV to our Recruitment Team who will review your details.
Regulatory Affairs Associate / Compliance Officer employer: Healthium Clinics
Healthium Clinics is an exceptional employer, offering a rewarding opportunity for Healthcare Assistants to make a meaningful impact on health and wellbeing across Oxfordshire. With a commitment to employee growth through structured onboarding and ongoing professional development, our forward-thinking culture fosters innovation and collaboration, while providing competitive benefits such as BUPA full cover, generous holiday allowances, and a supportive work environment that prioritises work-life balance.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Associate / Compliance Officer
✨Get Involved with Local Health Initiatives
Join local community health events or volunteer for organisations like public health agencies. This not only builds your experience but also helps you network with industry professionals who might know of openings at places like Healthium Clinics.
✨Tap into Professional Associations
Check out associations like the Institute of Healthcare Management. They often have job boards, networking events, and conferences that are perfect for connecting with potential employers in health sciences administration.
✨Stay Updated with Industry Trends
Follow health policy news and trends—being knowledgeable about the current landscape will not only help you in interviews but also make you stand out as a candidate. You can discuss recent developments and their implications when chatting with folks at Healthium Clinics.
✨Apply Through Our Website for Better Visibility
When you find roles that excite you, especially at places like Healthium Clinics, don’t forget to apply through our website. This can sometimes give you an edge by showing the employer you’re savvy and committed to finding the right fit.
We think you need these skills to ace Regulatory Affairs Associate / Compliance Officer
Some tips for your application 🫡
Highlight Your Relevant Experience:When applying for a role in health sciences administration, it's super important to spotlight any relevant experience you have in healthcare settings. Whether you've worked in a hospital, a clinic, or any related environment, make sure to detail those roles in your CV – focusing on your responsibilities and achievements that align with the job at Healthium Clinics.
Showcase Your Administrative Skills:Administrative skills are key in this field, so don’t hold back! Make sure your CV reflects your proficiency in things like scheduling, data management, and compliance with health regulations. Mention specific software you’ve used, such as patient management systems, as this will demonstrate your hands-on abilities and readiness for the role at Healthium Clinics.
Craft a Meaningful Cover Letter:Your cover letter should reflect your passion for the health sciences field and your eagerness to contribute to Healthium Clinics. Share a bit about why you’re drawn to this sector, any impactful situations or challenges you’ve encountered, and how they’ve shaped your desire to work in health sciences administration. This personal touch can really set you apart!
Tailor Your Documents to the Job:Don't use a one-size-fits-all approach! Make sure your CV and cover letter are specifically tailored for this role. Highlight any certifications you have relevant to health administration, and ensure you clearly connect your previous roles to the skills needed for the full-time position at Healthium Clinics. This way, you're showing them you’ve done your homework and are genuinely interested in being a part of their team.
How to prepare for a job interview at Healthium Clinics
✨Showcase Your Administrative Skills
In health sciences administration, being organised is key. Make sure you can demonstrate your skills in managing schedules, paperwork, and data accurately. Be ready to discuss specific tools you've used, like electronic health record systems or scheduling software, and how they improved efficiency in your past experiences.
✨Know Your Regulations
Familiarity with healthcare regulations and compliance is crucial. Brush up on HIPAA, GDPR, or other relevant policies before your interview. We recommend preparing examples of how you've ensured compliance or handled sensitive information in past roles—this will show you're not just knowledgeable but also responsible.
✨Prepare for Scenario Questions
Interviews for administrative roles often involve scenario-based questions to assess your problem-solving skills. Practice responses to common situations you might face, such as dealing with a challenging patient or managing a sudden schedule change. This will not only demonstrate your ability to think on your feet but also highlight your interpersonal skills.
✨Align Your Goals with the Organisation
As a full-time candidate, employers will want to know how your long-term career goals align with their mission. Take some time to research Healthium Clinics’s values and be ready to tie your passion for health sciences administration into their objectives. Demonstrating enthusiasm and career alignment can be a game-changer in this competitive field!
