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:
* A degree (or equivalent) in Life Sciences or a related discipline.
* 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.
* Background in post-market surveillance, vigilance, and recall management.
Regulatory Affairs Manager | Medical Devices | IVD | ISO 13485 | IVDR | 21 CFR 820 | Regulatory Compliance | Post-Market Surveillance | Risk Management | Vigilance | Cambridge Jobs