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Our client is seeking a motivated and well-organised Regulatory Affairs Specialist with experience in the medical device sector. This role is ideal for someone with a strong scientific background and a keen interest in regulatory compliance and product evaluation.
Key Responsibilities:
- Provide technical and administrative regulatory support for new medical device product submissions and evaluations
- Respond to regulatory compliance requests from internal and external stakeholders, including the provision of detailed product information
- Monitor departmental performance data and contribute to continuous process improvement initiatives
- Maintain and manage product information databases
- Research and review product-related information to support regulatory submissions
- Review and respond to customer specification requests
- Maintain and update regulatory reference materials to support departmental queries
- Monitor product changes to ensure continued compliance with both domestic and international regulatory requirements
- Source and distribute updates on international laws, standards, and guidelines
- Stay current on existing and emerging medical device regulations
- Review promotional materials, labelling, batch records, specification sheets, and test methods for regulatory compliance
Qualifications & Experience:
- A MSc or PhD in Materials Science, Engineering, Chemistry, or a related scientific discipline
- Minimum of 2 years' experience in regulatory affairs or compliance for medical devices or similar regulated products
- Solid understanding of global regulatory frameworks (e.g., FDA, MDR, ISO standards)
- Working knowledge of statistics, electronic documentation systems, and regulatory information systems
The Regulatory Affairs Specialist will have
- Strong planning, organisational, and prioritisation skills
- Excellent attention to detail
- Proven problem-solving and analytical abilities
- Clear and confident communicator at all levels
- Highly goal-driven and motivated
To apply for this position, candidates must be currently residing in the UK and eligible to work.
