Senior Medical Director, Medical Quality & Device Safety

AbbVie; Maidenhead; On-site; GBP 138,000 - 262,000; Full time

Job summary

AbbVie seeks a Senior Medical Director, Integrated Medical Quality and Device Safety, to provide medical quality and device safety expertise across the enterprise. You will assess safety signals, manage product quality issues, and guide benefit-risk evaluations while aligning with global regulatory requirements.

Lead medical risk management activities, collaborate with GPS Therapeutic Areas, and support inspections and regulatory interactions to advance patient safety and lifecycle quality

Qualifications

• MD/DO or equivalent medical degree with specialty residency and patient management experience.
• 3–5 years in drug safety, medical device safety, or related fields.
• Strong knowledge of FDA, EU MDR and international requirements.
• Experience evaluating complex safety signals and cross-functional risk assessments.
• Excellent written and verbal communication and presentation skills.

Responsibilities

• Perform medical assessment of complaints and adverse events to determine impact and escalation needs.
• Lead evaluation of safety signals and trends from post-market surveillance and literature.
• Contribute to PMSS/PMCF activities and integrate safety data into benefit-risk assessments.
• Provide medical input for risk management, HHA, and device risk activities throughout the lifecycle.
• Author/regulate submissions and responses for device safety and quality compliance.

Skills

MD/DO or equivalent

Patient management

Medical safety

Regulatory understanding

Communication skills

Education

MD/DO or equivalent medical degree with specialty residency

Job description

AbbVie seeks a Senior Medical Director, Integrated Medical Quality and Device Safety, to provide medical quality and device safety expertise across the enterprise. You will assess safety signals, manage product quality issues, and guide benefit-risk evaluations while aligning with global regulatory requirements.

Lead medical risk management activities, collaborate with GPS Therapeutic Areas, and support inspections and regulatory interactions to advance patient safety and lifecycle quality