Manager, Regulatory Affairs (Medtech)

Location: Audubon, Pennsylvania, United States

Company

hirify.global develops medical devices and surgical solutions for patients with musculoskeletal disorders.

What you will do

• Lead preparation, filing, and management of US and international regulatory submissions and registrations.
• Develop regulatory strategies for 510(k) submissions, IDE and PMA applications, protocols, study designs, and regulatory reports.
• Guide the US Regulatory team’s expertise, staffing, project management, technical writing, testing methods, and product knowledge.
• Collaborate with Product Development, Clinical Affairs, Quality, Management, researchers, surgeons, and FDA representatives.
• Review product changes, regulatory pathway determinations, Note-to-File documentation, labeling, and marketing materials.
• Ensure compliance with FDA 21 CFR regulations and applicable US and international requirements; travel up to 10%.

Requirements

• BS degree in engineering or a science-related field or equivalent; a master’s degree is preferred.
• At least 8 years of experience in the medical device industry or equivalent.
• At least 3 years of regulatory experience in the medical device industry, preferably with orthopedic or spinal devices.
• Demonstrated experience obtaining 510(k) clearance and experience with IDE and PMA approval, preferably panel-track PMA.
• Excellent verbal, written, and organizational skills with strong attention to detail.

Culture & Benefits

• Values are centered on innovation, customer focus, teamwork, and results-driven execution.
• Work involves collaboration with researchers, educators, surgeons, healthcare providers, and internal teams.
• Equal employment opportunity and an inclusive, respectful workplace.
• Reasonable accommodations are available for individuals with disabilities.