Regulatory Affairs Specialist (Medical Devices)

Location: Remote, US

Salary: $79,000–$119,000 annual, with bonus and/or incentive eligibility.

Company

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

What you will do

• Plan and execute regulatory activities needed to obtain and maintain global approvals for medical devices.
• Determine requirements for product submissions and regulatory filings in assigned markets.
• Recommend regulatory pathways and strategies to internal and external customers.
• Review technical documentation and supporting evidence for compliance with applicable requirements.
• Prepare and maintain regulatory filings, including responses to regulator questions and non-conformances.
• Support product labeling and claims substantiation while serving as a regulatory subject matter expert.

Requirements

• B.A. or B.S. degree in life sciences, engineering, medical technology, regulatory science, or a related field.
• At least 2 years of experience in medical device regulatory affairs or quality assurance.
• Applied knowledge of FDA regulations and guidelines.
• Ability to evaluate information for compliance with standards, laws, and regulations.
• Ability to communicate regulatory requirements, solve problems, and collaborate with internal and external groups.
• Travel required up to 5%.

Culture & Benefits

• Full-time employment with health insurance, life and disability coverage, 401(k) contributions, and paid time off.
• Continuing education and training opportunities.
• Employee assistance, employee resource groups, and employee service programs.
• Inclusive workplace focused on belonging, career growth, and equal employment opportunity.