MEDASIL SURGICAL LIMITED
Senior Regulatory Affairs Specialist - Medical Devices
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About Us
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 for delivering high-quality, audit-ready technical documentation
- Ensuring timely regulatory submissions and approvals
- Proactively identifying regulatory risks and recommending solution
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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
- Proven experience in:
- 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 EUDAMED
- Strong analytical, organisational, and communication skills
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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
If you are passionate about regulatory compliance and want to grow your career with Medasil Surgical Limited, we would love to hear from you.
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