Regulatory Affairs Lead

Regulatory Affairs Lead – MedTech

A growing MedTech company is seeking an experienced Regulatory Affairs Leader . The ideal candidate will act as the key liaison between the business, its products, and regulatory bodies, with responsibility across pre- and post-market regulatory activities.

We’re looking for someone with strong experience in Medical Devices/Technology regulatory frameworks (including FDA submissions and international standards) who can guide products from development through to market launch and beyond.

This individual will act as the expert in taking Class IIa products through the regulators and act as a standlone Subject Matter Expert in FDA510(k) and wider areas.

Key responsibilities:

• Provide regulatory guidance to internal teams and senior management, supporting the preparation and submission of regulatory documentation.
• Maintain and update regulatory files and tracking systems to ensure timely access to approval and renewal information.
• Ensure products comply with regional and international regulations and standards.
• Keep abreast of evolving legislation, guidelines and industry practices.
• Analyse and present scientific data to support new product approvals and renewals.
• Manage submission timelines for licence variations and renewals, ensuring deadlines are met.
• Prepare and review product labels, patient information leaflets and related documentation.
• Advise on product testing requirements and interpret clinical and technical data.
• Offer strategic regulatory input during product development and updates.
• Lead or coordinate regulatory inspections and audits.
• Liaise and negotiate with regulatory authorities to secure product authorisations.
• Support process improvements and provide compliance training and advice to teams.

About You:

• Strong industry experience operating in a Lead level role within Regulatory Affairs (E)
• Experience working with Medical Devices/Technology in a regulated environment; Class IIa devices and above (E)
• Candidates must have experience working with electronics based devices (E)
• Strong experience in leading FDA 510(k) submissions (E)
• Wider experience in 60601-1 and SaMD would be beneficial (D)
• Proven ability to manage regulatory processes, leading Class IIa device accreditation with regulators (E)
• Collaborative, organised and able to manage multiple projects and deadlines (E)

Candidates must have experience as a Lead within FDA510(k) and be at a level to work as a sole expert, and be able to visit the company office once a week.