At a Glance
- Tasks: Ensure regulatory compliance for medical devices and maintain technical documentation.
- Company: Join Medasil Surgical, a leading UK medical device company with a focus on quality.
- Benefits: Competitive salary, career development, and a collaborative work environment.
- Other info: Flexible working options and opportunities for career growth.
- Why this job: Make a real impact in healthcare by supporting patient care globally.
- Qualifications: 5+ years in Regulatory Affairs and a relevant degree required.
The predicted salary is between 51750 - 63250 £ per year.
Medasil Surgical Limited is a leading UK-based medical device company specialising in the design, manufacture, and supply of single-use surgical products.
With a strong reputation for quality, and customer focus, we are committed to delivering safe and effective solutions to healthcare professionals worldwide.
The Opportunity
We are looking for a Senior Regulatory Affairs Specialist to join our team in Leeds.
This role offers the opportunity to play a key part in maintaining and enhancing regulatory compliance across our product portfolio in a fast-paced and collaborative environment.
This is a Full-time position, mainly onsite with occasional flexible working possible.
Key Responsibilities
- Ensure compliance with all applicable medical device regulations, standards, and legislation
- Create, update, and maintain Technical Documentation and Technical Files
- Conduct regular reviews to ensure alignment with harmonised standards and regulatory requirements
- Perform regulatory gap analyses against new or updated standards
- Review and approve design changes, engineering updates, CAPA, and nonconformances for regulatory impact
- Monitor regulatory changes and support updates to SOPs and internal systems
- Manage and support product registrations with Competent Authorities (e. g., MHRA, EUDAMED)
- Ensure post-market surveillance activities are effectively integrated into Technical Documentation
- Review and approve labelling, promotional materials, and product claims
- Participate in internal and external audits
- Collaborate cross-functionally to support compliant product lifecycle management
- Responsible fordelivering high-quality, audit-ready technical documentation
- Ensuring timely regulatory submissions and approvals
- Proactively identifying regulatory risks and recommending solution
Skills & Experience
- Minimum 5 years’ experience in a Medical Device Regulatory Affairs role
- Bachelor’s degree in Science, Engineering, Regulatory Affairs, or related discipline
• Strong understanding of
- MDD 93/42/EEC, MDR 2017/745, and UKCA requirements
- ISO 13485 Quality Management Systems
- Creating and maintaining Technical Documentation
- Conducting regulatory gap analyses
- Interpreting and applying harmonised standards and regulatory guidance
- Reviewing design changes, CAPA, and nonconformances
- Post-market surveillance and Technical File maintenance
- Knowledge of risk management, clinical evaluation documentation, and labelling requirements
- Familiarity with device registration systems such as MHRA and EUDAMEDStrong analytical, organisational, and communication skills
Why Join Medasil?
- Be part of a respected and growing medical device company
- Work within a collaborative and quality-driven environment
- Opportunity to contribute to products that support patient care globally
- Career development within Regulatory Affairs
- Competitive salary dependent on experience.
Medasil Surgical Limited is an equal‑opportunity employer. We welcome applications from all qualified individuals regardless of background and identity
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Senior Regulatory Affairs Specialist - Medical Devices in Leeds employer: MEDASIL SURGICAL LIMITED
Medasil Surgical Limited is an exceptional employer, offering a dynamic and collaborative work environment in Leeds, where you can make a meaningful impact on patient care through innovative medical devices. With a strong commitment to employee growth, we provide opportunities for career development within Regulatory Affairs, alongside a competitive salary and the chance to work with a respected team dedicated to quality and compliance. Join us to be part of a company that values your contributions and supports your professional journey.
