Regulatory Affairs Leader (Medical Devices)

Location: New York, United States; Hybrid

Salary: $191,250–$233,750 per year, plus equity and full benefits

Company

hirify.global develops non-invasive, data-driven preventive healthcare technology combined with direct clinical care.

What you will do

• Build the US regulatory affairs function, including core processes, SOPs, and an in-region quality management system.
• Manage FDA relationships, device submissions, pre-submission and submission meetings, and US regulatory pathways.
• Develop a scalable state-by-state regulatory expansion process and represent the US market in global regulatory planning.
• Hold the US Agent, Initial Importer, and Medical Device Distributor roles.
• Manage post-market regulatory activity and contribute to the future structure of the US regulatory team.

Requirements

• 8+ years of medical device regulatory affairs experience, including at least 5 years with FDA-regulated devices.
• Accountable leadership of US 510(k), De Novo, or PMA clearances or approvals.
• Direct experience planning and leading FDA pre-submission and submission meetings.
• Eligibility and willingness to hold the US Agent, Initial Importer, and Medical Device Distributor roles.
• Experience building regulatory processes, SOPs, or teams in a scale-up or greenfield environment.
• Relevant degree and experience supporting clinical expansion into new markets or sites.

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 US regulatory function from scratch and shape how the work is done locally.
• Meaningful input into global regulatory decisions and portfolio strategy.
• Combination of strategic leadership and hands-on technical regulatory work.
• Support from an experienced Regulatory Affairs and Quality team.
• Competitive base salary, equity, and full benefits.