Senior Manager/Director of Regulatory Affairs
20 hours ago
A leading medical device and IVD manufacturer based in Cambridgeshire is looking for a Regulatory Affairs Manager . This company develops and supplies innovative diagnostic solutions used worldwide.
As a Regulatory Affairs Manager , you’ll play a key role in ensuring products meet global regulatory, safety, and quality standards from early development through to post-market support. You’ll lead regulatory strategy, guide compliance initiatives, and support the commercialisation of new and existing products across international markets.
Your responsibilities as the Regulatory Affairs Manager will include:
Leading and delivering regulatory strategies for new product launches, updates, and ongoing compliance.
Overseeing global submission preparation, approval processes, and regulatory documentation.
Acting as the regulatory lead on cross-functional project teams, offering clear, solution-driven advice.
Managing vigilance, recalls, risk management, and post-market surveillance activities.
Reviewing and approving labelling, promotional materials, and technical documentation for compliance.
Monitoring global regulatory changes and ensuring continued product conformity.
Supporting the Quality Management System (QMS) and maintaining ISO 13485 compliance.
Mentoring and developing junior regulatory team members.
Acting as the Person Responsible for Regulatory Compliance (PRRC) under IVDR, where qualified.
To be successful as the Regulatory Affairs Manager, you will need to demonstrate:
At least 8 years of experience in IVD and/or medical device regulatory affairs, preferably EU-focused.
A recognised qualification in Regulatory Affairs and evidence of continued professional development.
Proven ability to manage multiple projects and regulatory submissions independently.
Strong knowledge of ISO 13485 and global medical device regulatory frameworks.
In addition, the following will be advantageous for a Regulatory Affairs Manager:
Experience with FDA (21 CFR Part 820) and global regulatory bodies.
Regulatory Affairs Manager | Medical Devices | IVD | ISO 13485 | IVDR | 21 CFR 820 | Regulatory Compliance | Post-Market Surveillance | Risk Management | Vigilance | Cambridge Jobs
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