Director, Post Market Surveillance and Clinical Affairs (Medical Devices)

Location: Gainesville, FL, United States; onsite

Company

hirify.global develops orthopedic implants, instruments, and technologies designed to improve surgical experiences and patient mobility outcomes.

What you will do

• Lead the Post Market Quality Assurance and Clinical Affairs teams, setting strategy, priorities, resources, and performance expectations.
• Maintain compliant post-market and clinical processes under FDA, ISO, EU MDR, and international requirements.
• Oversee complaints, adverse events, incidents, recalls, field actions, safety signals, and regulatory reporting.
• Establish clinical strategy and evidence plans supporting product development, regulatory pathways, risk management, and lifecycle decisions.
• Direct clinical evaluations, PMCF, literature reviews, clinical investigations, and external research.
• Partner with Regulatory Affairs, R&D, Medical Affairs, Quality, Commercial teams, investigators, clinicians, and research organizations.

Requirements

• Bachelor’s degree in a related field; a master’s degree is preferred.
• 10+ years of progressive experience in FDA- and ISO-regulated medical devices, post-market quality, clinical affairs, clinical evidence, or related QMS processes.
• 5+ years of people leadership experience managing multidisciplinary teams, strategy, resources, and competing priorities.
• Strong knowledge of U.S. and international post-market, clinical evaluation, clinical investigation, vigilance, and Good Clinical Practice requirements, including FDA regulations, ISO 13485, ISO 14155, and EU MDR.
• Experience interpreting clinical and post-market data, identifying safety and performance signals, and translating evidence into regulatory, quality, and business decisions.
• Demonstrated technical writing experience in healthcare, science, or quality systems.

Nice to have

• Master’s degree in a related field.
• RN or comparable healthcare credential.

Culture & Benefits

• Innovation-focused work in orthopedic implants, instruments, and surgical technologies.
• Cross-functional collaboration across quality, regulatory, R&D, medical affairs, and commercial functions.
• Opportunity to support product safety, performance, clinical evidence, and patient mobility outcomes.

Hiring process

• Initial interview.
• Hiring manager and team interviews.
• Final selection followed by an offer.