Regulatory Specialist (Medical Devices)

Location: Audubon, Pennsylvania, United States

Company

hirify.global develops medical technologies and implant and instrument systems to improve surgical techniques and outcomes for patients with musculoskeletal disorders.

What you will do

• Prepare, review, obtain approvals for, and submit 510(k) applications to the FDA.
• Support IDE and PMA submissions, including clinical, non-clinical, and manufacturing sections.
• Coordinate regulatory documentation and submission timelines with Product Development, Clinical Affairs, management, and other functional teams.
• Respond to FDA requests and maintain approved PMAs through supplements and annual reports.
• Assess regulatory pathways for new or changed products and approve supporting documentation.
• Review document change orders, labeling, promotional materials, and regulatory SOPs for compliance.

Requirements

• Bachelor’s degree in a health- or science-related field or equivalent; an engineering degree is a plus.
• 2–5 years of Regulatory Affairs experience in the medical device industry, preferably with orthopedic devices.
• Experience with medical device development and product registration.
• Knowledge of U.S. regulatory submissions, including Pre-Sub and 510(k); IDE and PMA experience is a plus.
• Experience assessing regulatory impacts of product or process changes and reviewing labeling and promotional literature.
• Strong communication, time management, independent-working, teamwork, and Microsoft Office skills.

Culture & Benefits

• Full-time employment focused on innovation, patient care, customer focus, teamwork, and results.
• Collaboration with researchers, educators, surgeons, healthcare providers, and internal functional teams.
• Training is provided on relevant regulatory processes and company compliance requirements.
• Inclusive workplace with equal employment opportunity and reasonable accommodations available.
• Role includes physical requirements such as sitting, climbing or balancing, stooping, kneeling, crouching, crawling, and lifting up to 25 pounds occasionally.