Senior Med. Device Safety & Vigi. Lead (US/Raleigh)

About the role

You will lead the safety strategy and ongoing safety monitoring of medical devices and device constituent parts used with our medicines, from clinical development through post-market use. You will bring together clinical, scientific, quality and real-world information to identify emerging risks, assess whether device benefits continue to outweigh those risks, and determine appropriate actions. You will also guide safety decisions, prepare regulatory safety documentation and represent the function during audits and inspections.

Responsibilities

• Lead benefit-risk assessments and safety strategies for medical devices and device constituent parts of combination products, across clinical development and post-market use.
• Analyze clinical, complaint, quality, literature and real-world information to identify, evaluate and communicate emerging device-safety risks.
• Lead post-market surveillance, vigilance reporting and product-complaint safety malfunction assessments.
• Provide device-safety content for study documents, safety reports, product labelling, regulatory submissions and responses to health authorities.
• Represent Device Safety and Vigilance during audits and inspections, ensuring work meets regulatory, quality and company requirements.
• Lead, coordinate and provide strategic guidance to external partners and cross-functional stakeholders to ensure timely delivery of high-quality safety activities.

Qualifications

An advanced scientific or healthcare qualification, such as a doctoral degree, pharmacy doctorate, medical degree or equivalent experience.

Requirements

Substantial experience in clinical development, benefit-risk assessment, post-market surveillance, vigilance and risk management of medical devices or combination products. Experience assessing adverse events and device malfunctions and contributing to regulatory submissions and product lifecycle activities. Experience working with global health authorities and explaining complex clinical, scientific and technical information clearly.

Skills

Strong leadership and collaboration skills, including experience guiding teams, managing priorities and working across functions. Clear written and spoken English, sound judgement and a consistent focus on patient safety, ethical decisions and data integrity.

Pay

The reasonably anticipated salary range for this position is $184,000 to $241,500 per year. The actual salary offered will take into account related knowledge, skills, experience and location among other factors and may fall outside the expected range.

Schedule

Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.