Principal Regulatory Affairs (Medical Devices)

Location: Remote — Illinois, United States

Salary: $116,000–$174,000 annual, plus bonus and/or incentive eligibility

Company

hirify.global Industries is a growing worldwide medical technology organization providing medical products and regulatory support across international markets.

What you will do

• Develop regulatory strategies for global product approvals, launches, and ongoing product compliance.
• Determine submission and filing requirements across national and multinational markets.
• Lead regulatory submissions, including 510(k)s and CE Technical Files, and maintain supporting records.
• Communicate and negotiate with the FDA, notified bodies, and other regulatory authorities.
• Lead labeling, product claims, risk management, technical documentation, audits, and corrective actions.
• Manage complex cross-functional projects, improve regulatory processes, and guide future product development.

Requirements

• Bachelor’s degree in life sciences, engineering, medical technology, regulatory science, or a related field.
• 5+ years of diverse regulatory experience in the medical device industry.
• Experience with pre-market and post-market regulatory activities across multiple international markets.
• Extensive experience authoring regulatory submissions, including 510(k)s and CE Technical Files.
• Experience communicating and negotiating with regulatory agencies, including the FDA and notified bodies.
• Background in regulatory intelligence, risk management, and design and development activities.

Culture & Benefits

• Remote work arrangement for the Illinois-based role.
• Health insurance, life and disability coverage, 401(k) contributions, and paid time off for eligible employees.
• Continuing education and training opportunities.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access where applicable.
• Inclusive workplace focused on belonging, diversity, and career growth.