Regulatory Affairs Manager

Company Description NX Health Limited is an early-stage medical device company developing a non-invasive device for managing symptoms in neurological and neuropsychiatric disorders, progressing toward clinical trials and MHRA device registration.

Role Description We're hiring a Regulatory Affairs Manager to drive the regulatory strategy end to end — leading the path to UKCA (UK) and CE (EU) marking for a Class IIa device, and acting as our lead point of contact with MHRA, the NHS Innovation Service and NICE. This is a hands-on role at a small company: you'll own the regulatory function directly, working closely with our leadership teams rather than managing a larger department.

Full-time, permanent, hybrid (part remote / part office-based — see Working Arrangements).

Key Responsibilities

• Own and execute NX08's regulatory strategy for Class IIa device approval in the UK (UKCA) and EU (CE), under UK MDR 2002 and EU MDR 2017/745.

• Lead engagement with MHRA, including preparing and submitting the clinical investigation notification and driving it toward a "no objection" outcome.

• Build and manage the relationship with the NHS Innovation Service, and represent NX Health in conversations with NICE on routes to adoption within the UK healthcare system.

• Author and own the clinical investigation plan (CIP) and investigator's brochure (IB), both to ISO 14155:2026, working closely with the clinical team.

• Lead the technical documentation required for conformity assessment: risk management file (ISO 14971), clinical evaluation report, Design History File, labelling and instructions for use, and the post-market surveillance plan.

• Manage the relationship with our UK Approved Body and EU Notified Body, including booking conformity assessment and coordinating any EU Authorised Representative arrangement.

• Own HRA/REC approval via IRAS, run in parallel with the MHRA notification.

• Manage the regulatory budget, including external consultants and Approved Body fees, and track regulatory milestones against our Innovate UK/UKRI grant reporting obligations.

Personal Specifications - Essential Criteria

• Proven, hands-on experience managing Class IIa medical device approvals through to UKCA and/or CE marking.

• A track record of direct engagement with MHRA and NICE, with evidence of outcomes achieved, not just process familiarity.

• Has personally achieved a "no objection" decision from MHRA on a prior clinical investigation notification.

• Experience engaging with the NHS Innovation Service or an equivalent NHS innovation/adoption pathway.

• Able to independently author clinical investigation plans (CIPs) and investigator's brochures (IBs) to ISO 14155:2026.

• Working knowledge of UK MDR 2002 and EU MDR 2017/745 in parallel — able to manage both UKCA and CE routes at once, not just one regime.

• Strong written and verbal communication skills, comfortable representing the company directly to regulators and NHS stakeholders.

Person Specification - Desirable Criteria

• Experience managing a UK Approved Body or EU Notified Body relationship, including booking conformity assessment.

• Understanding of EU Authorised Representative requirements for a UK-based manufacturer placing devices on the EU market.

• Experience with IRAS submissions and HRA/REC approval.

• Familiarity with IEC 62304 and/or IEC 62366, where the device includes a software or usability component.

• Additional professional qualifications are preferred: RAC (Devices) certification from RAPS, or TOPRA membership/Diploma.

Working Arrangements

Hybrid role: part remote, part based at our Manchester office, 2-3 days in person. Full-time, permanent position. Some travel will be required for meetings with MHRA, the NHS Innovation Service, NICE, Approved Body/Notified Body contacts, and clinical trial sites.

How to Apply

Please send a CV and a short covering note setting out your relevant experience against the criteria above to danielko@nxhealth.co.uk, marked "Regulatory Affairs Manager".