Senior Regulatory Affairs Specialist (Medical Devices)

Location: Remote in Illinois, United States; up to 10% travel required

Salary: $92,000–$138,000 annual, plus bonus and/or incentive eligibility

Company

hirify.global is a worldwide medical technology organization providing medical products and related solutions.

What you will do

• Plan and execute complex global regulatory projects for new medical devices, launch markets, and post-market changes.
• Develop regulatory strategies, pathways, timelines, and solutions for product submissions and approvals.
• Lead preparation and maintenance of regulatory filings, including technical documentation, summary materials, labeling, and product claims.
• Evaluate supporting evidence against FDA regulations, guidance documents, standards, and other applicable requirements.
• Lead multifunctional teams, coordinate internal and external stakeholders, and respond to regulator questions and non-conformances.
• Support regulatory processes, compliance databases, audits, logs, and departmental records.

Requirements

• Bachelor’s degree in life science, engineering, medical technology, regulatory science, or a related field.
• At least 4 years of regulatory affairs experience in the medical device industry supporting domestic or international markets.
• Experience authoring and submitting 510(k) applications and/or CE Technical Files.
• Experience preparing responses and communicating with regulatory agencies.
• Applied knowledge of FDA regulations and guidelines, with the ability to assess compliance with standards, laws, and regulations.
• Must be based in Illinois; up to 10% travel is required.

Culture & Benefits

• Remote work arrangement.
• Health insurance, life and disability insurance, 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 for eligible employees.
• Inclusive workplace focused on belonging, diversity, and career growth.