Regulatory Affairs Department Lead (PRRC)
Location: Central Scotland with hybrid or remote working available
Salary: Negotiable depending on experience
We are recruiting for an experienced Regulatory Affairs Department Lead to join our client, a well-established and respected name in the medical device and in vitro diagnostics (IVD) industry. This is a senior leadership role where you'll oversee a small, capable team and take responsibility for regulatory compliance across multiple global markets, including the US, Canada, and Europe.
The focus is on someone who can bring real depth of experience with high-risk Class D devices, and who understands the complexities of IVDR, FDA and Health Canada regulations inside out. You'll need to be comfortable leading from the front, acting as PRRC, and steering technical documentation, submissions, and post-market activities through a constantly evolving regulatory landscape.
What you'll be doing:
* Lead and develop the Regulatory Affairs department, managing a small team
* Oversee preparation, review and maintenance of technical documentation and submissions for Class D IVD devices (IVDR, FDA 510(k)/PMA, Health Canada)
* Act as Person Responsible for Regulatory Compliance (PRRC) and ensure compliance with GMP and ISO13485
* Support post-market surveillance, vigilance and risk management processes
* Act as a key point of contact with regulatory bodies and external partners
* Work closely with other departments to align regulatory work with wider business priorities
* Maintain a regular on-site presence, with flexibility around hybrid or remote working
What you'll need:
* Extensive regulatory affairs experience within IVD or medical devices
* Proven track record with regulatory submissions for high-risk Class D devices
* Strong knowledge of IVDR, FDA and Canadian medical device regulations
* Hands-on experience of post-market compliance, risk and vigilance activities
* People management experience, with the ability to lead and mentor a team
* A collaborative approach and the confidence to work with internal stakeholders and regulatory bodies
* Fluent English and excellent communication skills
* Must already have the right to work in the UK
What next?
If you're looking for a senior role where you can make a real impact and bring your expertise to a high-performing team, we'd love to hear from you. Send your CV or contact us to find out more.