Regulatory Affairs Specialist

Regulatory Affairs Specialist

Job Type: Full time - Permanent

Location: Madison, New Jersey (On-site)

A commercial-stage transplant technology company, part of a global medtech group, is changing how donor organs are preserved and assessed before transplant. Their flagship platform is already used in thousands of procedures across the US, Europe, Canada and Australia, and they are growing their Regulatory Affairs team to support the next phase of expansion.

They are now looking for a Regulatory Affairs Specialist to support global submissions and take ownership of the regulatory information that sits behind every market.

What you'll do:

• Support the preparation, compilation and submission of regulatory filings across the US, EU, Canada, Australia and other markets


• Coordinate deliverables with colleagues covering software, hardware, disposables and labelling


• Support interactions with regulatory authorities and Notified Bodies


• Own and reconcile regulatory records: registrations, approvals, certificates, licenses and market status


• Help configure, improve and report from the company's regulatory information management system (Rimsys)


• Keep regulatory records aligned with change control and approved product configurations


• Support renewals, annual reports and other recurring regulatory obligations

What you'll bring:

• Bachelor's degree in Engineering, Life Sciences or a related technical discipline


• 3+ years of regulatory affairs experience in medical devices or a similar industry


• Working knowledge of FDA regulatory processes, plus at least one international market (EU, Canada or Australia)


• Experience with regulatory information management systems (Rimsys preferred)


• Excellent organization, attention to detail and technical writing skills


• Comfortable working cross-functionally with Quality, Manufacturing, R&D, Clinical and Marketing

This is a chance to join a mission-driven medtech business with the backing of a global group, in a role where the quality of your data and documentation directly supports getting life-saving technology to more patients. Hybrid working, with around 5% travel.