The SureScreen Group
Regulatory Affairs Specialist (IVDR) – Fixed Term Contract
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About the Role
SureScreen Diagnostics is an innovative and forward-thinking company, specialising in creating bespoke diagnostic solutions, products, and tailored services across the UK and Europe for over 30 years. Their mission is to deliver high-quality diagnostic products that exceed customer expectations at a fair price.
The company thrives on a diverse, talented, and dynamic team, offering a supportive, challenging, and rewarding environment to help individuals expand their knowledge, build connections, and grow professionally.
They are seeking a Regulatory Affairs Specialist to support the transition to IVDR across their product portfolio. This is a fixed-term contract (12 months), with a realistic possibility of extension or conversion to a permanent position (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 Responsibilities
IVDR Compliance, Technical Documentation & NPD Support
- Prepare, review, and maintain IVDR Technical Documentation, including associated regulatory records.
- Support IVDR conformity assessment activities, particularly Notified Body submissions.
- Provide regulatory input into New Product Development (NPD), embedding IVDR requirements from design through to product launch and lifecycle management.
- Assess the regulatory impact of product changes, including design, labelling, manufacturing updates, and supplier modifications.
- Review and maintain Instructions for Use (IFUs), labelling, declarations of conformity, and regulatory claims.
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Regulatory Operations & Post-Market Activities
- Support UDI (Unique Device Identification) 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 regulatory and standards changes, assessing their impact on the business.
- Contribute to improvements in regulatory processes and systems.
Key Relationships
Internal:
- Regulatory Affairs Manager
- R&D Team
- Sales
- Marketing
- Operations (including production)
- Quality
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External:
- Regulatory authorities
- Notified Bodies
Qualifications, Skills & Experience
- A degree in Life Sciences, Biomedical Sciences, Regulatory Affairs, Pharmacy, Engineering, or a related discipline.
- Minimum 5 years' experience in Regulatory Affairs, preferably within the medical device or IVD industry.
- Strong knowledge of IVDR (EU 2017/746), ISO 13485, and related regulatory compliance requirements.
- Experience in 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, ability to manage multiple priorities, and meet deadlines.
- Excellent written and verbal communication skills.
- High attention to detail.
- Strong sense of urgency and self-motivation.
- Displays a can-do attitude with a positive approach.
For further details, visit: www.surescreen.com
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