Director, Post Market Surveillance and Clinical Affairs

Department: Quality

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Chief, QARACA Officer

Description

• Post-market surveillance, complaints, vigilance, MDRs, recalls, field actions, and EUDAMED reporting 
• Clinical strategy, evidence planning, evaluations, literature reviews, and state-of-the-art assessments 
• Post-market clinical follow-up (PMCF) planning and reporting 
• Clinical investigations, external research, and clinical support for submissions, claims, and risk management

Key Responsibilities

• Leads and develops the Post Market Quality Assurance and Clinical Affairs teams; sets strategy, priorities, resources, and performance expectations.
• Maintains compliant, effective post-market and clinical processes under applicable FDA, ISO, EU MDR, and international requirements.
• Oversees collection, trending, assessment, escalation, and reporting of complaints, adverse events, incidents, recalls, field actions, and other safety signals.
• Directs communications and required reporting to FDA and international regulatory authorities.
• Establishes global clinical strategy and evidence plans aligned with product development, regulatory pathways, risk management, and business priorities.
• Oversees clinical evaluations, PMCF, literature reviews, and related documentation demonstrating product safety, performance, and benefit-risk acceptability.
• Provides governance for clinical investigations and external research, including protocols, vendors, sites, data quality, safety escalation, budgets, timelines, and Good Clinical Practice compliance.
• Partners with Regulatory Affairs, R&D, Medical Affairs, Quality, and Commercial teams to support submissions, labeling, claims, risk management, and lifecycle decisions.
• Provides management review inputs, monitors regulatory changes, approves applicable QMS documentation, and leads continuous improvement initiatives.
• Supports regulatory, customer, and third-party audits and provides compliance guidance.
• Builds effective relationships with investigators, clinicians, key opinion leaders, contract research organizations, and other external partners while modeling Advita Values.

Skills Knowledge and Expertise

• Bachelor’s degree in a related field required; master’s degree preferred.

• 10+ years of progressive experience in FDA/ISO-regulated medical devices, with substantial responsibility for post-market quality, clinical affairs, clinical evidence, or related QMS processes.
• 5+ years of people leadership experience directing multidisciplinary teams, strategy, resources, and competing priorities.
• Demonstrated technical writing experience in healthcare, science, or quality systems.
• RN or comparable healthcare credential preferred.

• Strong knowledge of U.S. and international post-market, clinical evaluation, clinical investigation, vigilance, and Good Clinical Practice requirements, including applicable FDA regulations, ISO 13485, ISO 14155, and EU MDR.
• Ability to interpret clinical and post-market data, identify safety and performance signals, and translate evidence into clear regulatory, quality, and business decisions.