Senior Medical Director, Device Safety & Quality

AbbVie Inc.; Maidenhead; On-site; GBP 150,000 - 190,000; Full time

Job summary

AbbVie Inc. in Maidenhead seeks a Senior Medical Director to provide medical quality and device safety expertise across AbbVie's portfolio, partnering with Global Patient Safety and cross-enterprise stakeholders.

You will lead medical risk assessments, manage safety signals, and guide benefit-risk evaluations while supporting regulatory submissions and inspections. Strong communication and regulatory knowledge are essential.

Qualifications

• MD, DO, or equivalent medical degree with specialty residency and minimum 2 years of patient management experience.
• 3–5 years of experience in drug safety, medical device safety, clinical development, pharmacovigilance, regulatory science, or related functions.
• Strong understanding of global medical device regulations, including FDA, EU MDR, and other international requirements.
• Experience evaluating complex safety signals and contributing to cross-functional risk assessments.
• Excellent written, verbal, and presentation communication skills.

Responsibilities

• Perform medical assessment of product complaints, adverse events, and product quality issues to determine potential patient impact, reportability, and need for escalation.
• Lead evaluation of safety signals, adverse event trends, and emerging risks from post-market surveillance, literature, clinical studies, and other data sources.
• Contribute to and review PMSS and PMCF activities, ensuring integration of safety data into ongoing benefit-risk assessments.
• Provide medical expertise for Quality Risk Management activities, including benefit-risk evaluations, risk mitigation plans, and cross-functional risk reviews.
• Serve as a medical safety expert accountable for Health Hazard Assessments for quality and device-related issues.
• Provide medical input and oversight for Device Risk Management activities throughout the product lifecycle, ensuring risks are identified, evaluated, monitored and controlled.
• Author, review, and contribute to regulatory submissions, health authority responses, and other regulatory communications related to device safety, product quality, and risk management.
• Support inspections, audits, and health authority interactions by serving as a subject matter expert for medical device safety, vigilance, and risk management.

Skills

Communication skills

Risk assessment

Regulatory science

Medical expertise

Education

MD/DO or equivalent medical degree

Job description

AbbVie Inc. in Maidenhead seeks a Senior Medical Director to provide medical quality and device safety expertise across AbbVie's portfolio, partnering with Global Patient Safety and cross-enterprise stakeholders.

You will lead medical risk assessments, manage safety signals, and guide benefit-risk evaluations while supporting regulatory submissions and inspections. Strong communication and regulatory knowledge are essential.