Senior Medical Director, Integrated Medical Quality and Device Safety
Core
Senior medical expert providing strategic guidance on benefit-risk evaluations, risk mitigation, and safety signal management for AbbVie's global portfolio of medical devices and combination products.
Role type
Senior IC medical director (device safety and quality)
Builds
Safety strategies, risk mitigation plans, and regulatory submissions for medical devices
Domain
Healthcare / Medical Device Safety / Pharmacovigilance
Required skills
Medical degree (MD/DO), patient management, drug/device safety, clinical development, pharmacovigilance, regulatory science, global medical device regulations (FDA/EU MDR), complex safety signal evaluation
Preferred skills
Combination products, connected/digital medical devices, regulatory inspections, health authority interactions, risk management systems, product lifecycle management
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 (QRM) and benefit-risk evaluations; Author and review regulatory submissions and health authority responses; Support internal and external inspections and audits
Seniority
Senior, hands-on IC