Director, Post Market Surveillance and Clinical Affairs

Leads the integrated Post Market Quality Assurance and Clinical Affairs functions, ensuring a compliant, effective QMS; timely identification and management of post-market signals; and development of clinical evidence supporting product safety, performance, and lifecycle decisions. Key areas include: 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 Education: Bachelor’s degree in a related field required; master’s degree preferred. Experience: 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. Functional/Technical Knowledge, Skills and Abilities Required: 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.