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Regulatory Affairs Manager
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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.
Responsibilities
- Lead 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.
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Requirements
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- Degree 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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