International Regulatory Specialist (Medical Devices)

Location: Audubon, Pennsylvania, United States

Company

hirify.global develops medical technologies and solutions for musculoskeletal surgery to improve patient care and surgical outcomes.

What you will do

• Prepare, review, submit, and obtain approval for international regulatory submissions, including CE technical files and other country filings.
• Coordinate with Product Development, Quality Assurance, management, and international staff on product registrations and marketing clearances.
• Assess regulatory impacts of manufacturing, process, procedure, and design changes.
• Review and submit product labeling and promotional materials for markets outside the United States.
• Maintain approved regulatory files, prepare amendments, file Certificates to Foreign Governments with the FDA, and develop regulatory SOPs.
• Ensure compliance with ISO, CE, FDA, and other international and local regulations; travel may be required up to 10% of the time.

Requirements

• BS degree in a health- or science-related field; an engineering degree is a plus.
• 2–5 years of Regulatory Affairs experience in the medical device industry, preferably with orthopedic medical devices.
• Experience with medical device development, product registration, international registration requirements, and regulatory documentation.
• Knowledge of regulatory requirements in EMEA, Japan, Brazil, and other key geographies.
• Experience assessing regulatory impacts of product and process changes and reviewing labeling and promotional literature.
• Strong communication, time management, organizational, independent-work, and teamwork skills; proficiency with Microsoft Office.

Culture & Benefits

• Work is guided by innovation, customer focus, teamwork, and a driven, results-oriented approach.
• Collaboration with researchers, educators, healthcare providers, and cross-functional teams.
• Commitment to ethical business practices, regulatory compliance, inclusion, and equal employment opportunity.
• Physical requirements include sitting, climbing or balancing, crouching or crawling, and lifting up to 25 pounds occasionally.