Senior Regulatory Affairs Specialist (Medical Devices)

Location: Remote, US; up to 10% travel required

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

Company

hirify.global is a growing worldwide medical device organization offering regulatory, healthcare, and employee development programs.

What you will do

• Plan and execute critical global regulatory projects for new devices, market launches, and post-market changes.
• Develop regulatory strategies, pathways, submissions, filings, and supporting documentation for assigned markets.
• Lead multifunctional teams, define project timelines, and recommend solutions for complex regulatory issues.
• Review technical evidence, product labeling, claims, standards, and compliance records.
• Respond to regulatory agency questions and non-conformances, and participate in internal and external audits.
• Maintain regulatory databases, logs, files, and department processes.

Requirements

• B.A. or B.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)s and/or CE Technical Files.
• Experience preparing responses and communicating with regulatory agencies.
• Applied knowledge of FDA regulations and guidelines, with the ability to evaluate compliance with standards, laws, and regulations.
• Must be located in the US; remote work is available with up to 10% travel.

Culture & Benefits

• Competitive total rewards package.
• Continuing education and training opportunities.
• Health insurance, life and disability coverage, 401(k) contributions, and paid time off for eligible employees.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access.
• Inclusive workplace focused on belonging, diversity, and career growth.