At a Glance
- Tasks: Drive IVDR transition, manage compliance, and support regulatory submissions for innovative diagnostic products.
- Company: SureScreen Diagnostics, a forward-thinking company with over 30 years of experience.
- Benefits: Friendly environment, professional growth opportunities, and potential for contract extension.
- Other info: Collaborate with diverse teams and contribute to continuous improvement in regulatory processes.
- Why this job: Join a dynamic team and make a real impact in the medical device industry.
- Qualifications: Degree in relevant field and 5 years' experience in Regulatory Affairs.
The predicted salary is between 45000 - 55000 £ per year.
Sure Screen Diagnostics are an innovative and forward-thinking company creating bespoke diagnostic solutions, products and tailored services for organisations across the UK and Europe for over 30 years.
Our mission is to provide the best quality diagnostic products that meet and exceed customers’ expectations at a fair price.
We pride ourselves on having a diverse range of talented, hardworking and dynamic individuals within our team.
We provide a friendly, challenging and rewarding environment that will help individuals expand their knowledge, build connections and grow professionally.
We are looking for a Regulatory Affairs Specialist to help support the transition to IVDR for our product portfolio.
This is a fixed term contract of 12 months with a real possibility of extension or permanent position through this is not guaranteed.
Job Purpose
To drive the transition to IVDR across the product range, ensuring robust technical documentation, supporting regulatory submissions, and managing product lifecycle activities to maintain ongoing compliance and market access.
Key Accountabilities and Responsibilities
- IVDR Compliance, Technical Documentation & NPD Support
- Prepare, review, and maintain IVDR Technical Documentation and associated regulatory records.
- Support IVDR conformity assessment activities, including Notified Body submissions.
- Provide regulatory input into New Product Development (NPD), ensuring IVDR requirements are embedded from design through to launch and lifecycle management.
- Assess regulatory impact of product changes, including design, labelling, manufacturing, and supplier updates.
- Review and maintain Instructions for Use (IFUs), labelling, declarations of conformity, and regulatory claims.
- Regulatory Operations & Post-Market Activities
- Support UDI implementation, EUDAMED registrations, and device data management.
- Contribute to Post-Market Surveillance (PMS), vigilance reporting, and Field Safety Corrective Actions (FSCAs).
- Audit, Regulatory Intelligence & Continuous Improvement
- Support internal and external audits and regulatory inspections.
- Monitor changes in regulations and standards, assessing business impact.
- Contribute to improvements in regulatory processes and systems.
Key Relationships
- Internal
- Regulatory Affairs Manager
- R&D Team
- Sales
- Marketing
- Operations inc. production
- Quality
- External
- Regulatory authorities
- Notified bodies
Qualifications, skills, and experience
- Degree in Life Sciences, Biomedical Sciences, Regulatory Affairs, Pharmacy, Engineering, or a related discipline
- Minimum 5 years’ Regulatory Affairs experience within the medical device or IVD industry
- Strong knowledge of IVDR (EU 2017/746), ISO 13485, and regulatory compliance requirements
- Experience preparing and maintaining IVD Technical Documentation
- Experience supporting Notified Body audits, submissions, and regulatory projects
- Familiarity with UDI, EUDAMED, PMS, Vigilance, and risk management activities
- Strong organisational skills with the ability to manage multiple priorities and meet deadlines
- Excellent written and verbal communication skills
- Has good attention to detail
- Has a strong sense of urgency
- Is self‑motivated
- Displays a positive can-do‑it attitude
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Regulatory Affairs Specialist (IVDR) – Fixed Term Contract employer: surescreengroup
SureScreen Diagnostics is an exceptional employer that fosters a friendly and dynamic work environment, encouraging professional growth and knowledge expansion. With over 30 years of experience in bespoke diagnostic solutions, we offer our employees the opportunity to engage in meaningful work while contributing to innovative projects in the medical device sector. Our commitment to diversity and collaboration ensures that every team member can thrive and make a significant impact on our mission to deliver high-quality diagnostic products.
