Derby, England, United Kingdom · On-site
SureScreen 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 …
Skills: IVDR Compliance, Technical Documentation, ISO 13485, Notified Body Submissions, New Product Development
Derby, England, United Kingdom • On-site
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Drive the transition to IVDR across the product range by preparing robust technical documentation and supporting regulatory submissions. Manage product lifecycle activities, including post-market surveillance and EUDAMED registrations, to maintain market access.
Requires a degree in Life Sciences or a related field and at least 5 years of regulatory affairs experience in the medical device or IVD industry. Must possess strong knowledge of IVDR (EU 2017/746) and ISO 13485 standards.
SureScreen 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
Regulatory Operations & Post-Market Activities
Audit, Regulatory Intelligence & Continuous Improvement
Key Relationships:
Internal
External
Qualifications, skills, and experience:
See our website here for more info: www.surescreen.com
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