About the job

Regulatory Manager – IVD / Medical Devices

A growing diagnostics company developing innovative technologies is seeking an experienced Regulatory Manager to lead regulatory activities through product development and commercialization.

• ResponsibilitiesLead Regulatory Affairs for medical devices, IVDs, software-based diagnostics and genomic technologies.
• Develop and maintain technical documentation in line with EU IVDR, MDR and applicable international requirements.
• Develop regulatory strategies for new products, changes and lifecycle management.
• Prepare technical files, risk management, clinical/performance evaluation and PMS documentation.
• Provide regulatory input across design, verification, validation and change control.
• Support regulatory submissions, Notified Body interactions and market access in the EU, UK and other markets.
• Work closely with R&D, Software, Clinical, Bioinformatics and Quality teams.
• Monitor regulatory and standards changes and assess their impact.

• RequirementsDegree in Life Sciences, Biomedical Science, Molecular Biology, Genetics or a related field.
• Significant Regulatory Affairs experience in medical devices and/or IVDs.
• Strong knowledge of EU IVDR and MDR.
• Experience developing technical documentation and supporting regulatory submissions.
• Understanding of SaMD, software validation and IEC 62304.
• Knowledge of ISO 14971, ISO 13485, design controls and lifecycle management.
• Experience with CERs, PERs, PMS and related regulatory documentation.
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