About the Role
Clinica Engineering Medical Solutions Ltd is looking for a Medical Device Regulatory Affairs Specialist to join our team at Green Park Business Park in Reading. You will support the registration, regulatory compliance, and ongoing market approval of medical devices and healthcare technology solutions.
This role is suited to a detail-oriented regulatory professional who understands how technical documentation, quality standards, clinical evidence, and regulatory requirements contribute to safe and compliant medical products. You will work closely with engineering, quality assurance, clinical, product development, and commercial teams throughout the product lifecycle.
Key Responsibilities
- Prepare, review, and maintain regulatory documentation for medical devices and healthcare technology products.
- Support product registrations, licence applications, and regulatory submissions in the United Kingdom and other relevant markets.
- Assist with UKCA and CE-marking activities for applicable medical devices.
- Maintain technical files, declarations of conformity, product classifications, and supporting documentation.
- Review product specifications, labelling, instructions for use, and promotional materials for regulatory compliance.
- Monitor changes to medical-device regulations, standards, and regulatory guidance.
- Conduct regulatory assessments for product modifications, software updates, and manufacturing changes.
- Support post-market surveillance and vigilance reporting activities.
- Assist with the investigation and documentation of complaints, adverse events, and field safety issues.
- Work with engineering teams to ensure regulatory requirements are considered during product development.
- Support internal and external regulatory inspections and quality audits.
- Maintain accurate regulatory submission records, approval documents, and compliance databases.
- Coordinate with authorised representatives, notified bodies, external consultants, and regulatory authorities.
- Contribute to risk-management activities and the preparation of product risk documentation.
- Provide regulatory guidance to internal teams regarding new and existing products.
What We Are Looking For
- At least 2–4 years of experience in medical-device regulatory affairs, quality assurance, pharmaceutical compliance, or a related field.
- Good understanding of United Kingdom medical-device regulations.
- Familiarity with UKCA marking, CE marking, and medical-device classification requirements.
- Experience preparing or maintaining technical documentation for regulated products.
- Knowledge of quality-management systems and regulatory documentation controls.
- Understanding of ISO 13485 and medical-device risk-management principles.
- Ability to interpret complex regulatory standards and communicate requirements clearly.
- Strong written communication and technical documentation skills.
- Excellent organisation, accuracy, and attention to detail.
- Ability to manage several submissions, documentation projects, and deadlines simultaneously.
- Strong written and spoken English.
- A degree in biomedical engineering, life sciences, pharmacy, healthcare technology, regulatory affairs, or a related discipline is preferred.
Preferred Skills
- Experience working with software as a medical device or digitally connected healthcare products.
- Knowledge of ISO 14971 risk-management requirements.
- Familiarity with clinical evaluations and post-market clinical follow-up documentation.
- Experience supporting regulatory submissions outside the United Kingdom.
- Knowledge of European Union Medical Device Regulation requirements.
- Familiarity with corrective and preventive action processes.
- Experience participating in notified-body, regulatory-authority, or customer audits.
- Professional certification or additional training in medical-device regulatory affairs.
- Understanding of data-protection and cybersecurity requirements for connected medical devices.
Mindset
You are methodical, responsible, and comfortable working in a highly regulated environment. You understand that incomplete documentation or overlooked regulatory details can affect product approval, patient safety, and commercial operations.
You take ownership of your work, raise potential compliance issues early, and communicate regulatory requirements clearly to both technical and non-technical colleagues. You remain calm under deadlines and balance commercial priorities with the need to maintain high regulatory and ethical standards.
Pay: £3,700.00-£4,200.00 per month
Work Location: In person
