Senior Director, Post-Market Surveillance & Clinical Strategy

Advita Ortho, LLC; Gainesville (FL); On-site; USD 150,000 - 190,000; Full time

Job summary

Advita Ortho, LLC seeks a Director of Post Market Surveillance and Clinical Affairs to lead the integrated post-market quality assurance and clinical affairs functions in Gainesville, FL. You will drive compliance, evidence planning, PMCF, and regulatory reporting to support product safety and lifecycle decisions.

The role requires extensive FDA/ISO-regulated medical device experience, leadership of cross-functional teams, and strong technical writing skills, with a focus on risk management and

Qualifications

• 10+ years of progressive experience in FDA/ISO-regulated medical devices with post-market responsibility.
• 5+ years leading multidisciplinary teams, managing strategy and resources.
• Demonstrated technical writing experience in healthcare or quality systems.

Responsibilities

• Lead Post Market Quality Assurance and Clinical Affairs teams; set strategy and priorities.
• Maintain compliance with FDA, ISO, EU MDR, and international requirements.
• Oversee collection, trending, escalation, and reporting of complaints and safety signals.
• Direct communications and required reporting to FDA and regulatory authorities.
• Establish global clinical strategy and evidence plans aligned with product lifecycle decisions.

Skills

Regulatory knowledge

Clinical leadership

Technical writing

FDA/ISO regs

Education

Bachelor's degree

Master's degree preferred

Job description

Advita Ortho, LLC seeks a Director of Post Market Surveillance and Clinical Affairs to lead the integrated post-market quality assurance and clinical affairs functions in Gainesville, FL. You will drive compliance, evidence planning, PMCF, and regulatory reporting to support product safety and lifecycle decisions.

The role requires extensive FDA/ISO-regulated medical device experience, leadership of cross-functional teams, and strong technical writing skills, with a focus on risk management and