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
- 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.
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.
