Regulatory Leader (Medical Devices)

Location: London, United Kingdom — hybrid. The role is based in the UK and supports regulatory activity across EMEA.

Company

hirify.global develops non-invasive, data-driven preventative healthcare technology combining proprietary technology with direct clinical care.

What you will do

• Build the EMEA regulatory affairs function, including core processes, SOPs, and an in-region quality management system.
• Hold the UK Responsible Person role and manage Neko’s relationship with the MHRA.
• Develop a scalable, country-by-country regulatory expansion process across EMEA.
• Align regulatory positions across the UK, EU, and other jurisdictions and manage post-market activity.
• Contribute to EMEA and global regulatory strategy and define the future regional team.

Requirements

• 8+ years of experience in medical device regulatory affairs, including at least 5 years focused on UK, EU, or EMEA-regulated devices.
• Accountable leadership experience for CE marking under EU MDR or equivalent EMEA clearances.
• Experience planning and leading pre-submission and submission meetings with the MHRA or other EMEA authorities.
• Eligibility and willingness to hold the Statutory UK Responsible Person role.
• Experience building processes, SOPs, or teams in a scale-up or greenfield environment, plus a relevant degree.
• Hands-on experience using AI for regulatory intelligence, documentation, and workflow automation with appropriate expert oversight.

Nice to have

• Software as a Medical Device experience alongside a hardware device background.
• Experience partnering with product development teams in medtech or healthtech engineering.
• Experience building or scaling a regional regulatory team.

Culture & Benefits

• Opportunity to build the EMEA regulatory function, processes, team, and operating model from the ground up.
• Influence over global regulatory decisions and portfolio strategy from the start.
• Ownership of the UK and EMEA market within a global regulatory framework.
• Combination of strategic direction and hands-on technical regulatory work.
• Support from an experienced Regulatory Affairs and Quality team in Sweden.
• Competitive package including base salary, equity, and full benefits.