Copy of Senior Medical Director, Integrated Medical Quality and Device Safety
Core
Senior Medical Director providing medical quality and device safety expertise, leading assessment and management of safety signals, product quality issues, and emerging risks across the AbbVie portfolio.
Role type
Senior Medical Director (Medical Quality & Device Safety)
Builds
Medical safety assessments, risk mitigation plans, regulatory submissions, and benefit-risk evaluations for medical devices and combination products.
Domain
Healthcare / Medical Devices / Pharmacovigilance
Required skills
Medical degree (MD/DO) with specialty residency, patient management experience, drug/device safety expertise, global medical device regulations knowledge, safety signal evaluation, cross-functional risk assessment
Preferred skills
Combination products experience, connected/digital medical devices, regulatory inspection support, advanced risk management systems knowledge
Technologies
FDA, EU MDR, Post-Market Surveillance System (PMSS), Post-Market Clinical Follow-Up (PMCF)
Responsibilities
Perform medical assessment of product complaints and adverse events; Lead evaluation of safety signals and emerging risks; Provide medical expertise for Quality Risk Management and Device Risk Management; Author and review regulatory submissions and health authority responses; Support internal and external inspections and audits.
Seniority
Senior, hands-on IC