Regulatory Associate (Medical Devices)

Location: Audubon, Pennsylvania, United States

Company

hirify.global develops orthopedic medical devices and surgical solutions designed to improve outcomes for patients with musculoskeletal disorders.

What you will do

• Prepare, review, finalize, and submit 510(k) submissions for Class II products.
• Assist with IDE submissions for clinical trials and PMA packages covering clinical, manufacturing, and non-clinical sections.
• Respond to FDA requests and coordinate timely contributions from Product Development, Clinical Affairs, manufacturing, and other internal functions.
• Review clinical study data, Document Change Orders, labeling changes, and regulatory pathway determinations.
• Maintain approved PMAs through supplements, annual reports, Note-to-File documentation, and regulatory filing activities.
• Maintain knowledge of the company’s implant and instrument systems, surgical techniques, and applicable compliance requirements.

Requirements

• Bachelor’s degree in a health- or science-related field or equivalent; an engineering degree is a plus.
• Knowledge of United States Code of Federal Regulations Title 21 and FDA regulations.
• 0–2 years of experience in the medical device industry or an equivalent background; orthopedic device experience is preferred.
• Strong communication, listening, time management, and organizational skills.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Teams.
• Ability to work independently and collaboratively on multiple projects.

Culture & Benefits

• Work within a patient-focused medical technology environment centered on innovation and improved surgical outcomes.
• Collaborate with researchers, educators, surgeons, healthcare providers, and cross-functional internal teams.
• Culture built around innovation, customer focus, teamwork, and driven execution.
• Equal opportunity workplace committed to inclusion and respectful collaboration.
• Physical activities include sitting, climbing or balancing, kneeling, crouching, crawling, and lifting up to 25 pounds occasionally.