Director Medical Device Safety

Bayer - Hanover, NJ

Full-time - Senior

Hanover, NJ

Professional, Scientific, and Technical Services

About the position

The Director of Medical Device Safety (MDS) at Bayer is responsible for leading and developing global Pharmacovigilance (PV) processes and analyzing clinical data related to complaint handling, regulatory reporting, and clinical development for medical devices and combination products. This role involves providing safety oversight, contributing to design control, and ensuring compliance with medical device regulations, particularly the European Medical Device Regulation 2017/745. The Director will also serve as the Deputy Person Responsible for Regulatory Compliance Safety (PRRC-Safety Officer), overseeing vigilance reporting and post-marketing surveillance.

Responsibilities

• Generate concepts and define strategies for medical device post-marketing surveillance (PMS) and vigilance standards.
• Serve as the Deputy Person Responsible for Regulatory Compliance Safety (PRRC-Safety Officer) ensuring compliance with Medical Device Regulation 2017/745.
• Manage and provide content contributions to the medical device vigilance system, including reporting to health authorities worldwide.
• Manage post-marketing surveillance program activities, including documentation and report management.
• Provide contributions to design control for medical devices throughout the development process.
• Interpret global regulations and recommend modifications to operational procedures for compliance.
• Represent PVMDS during Health Authority inspections and Notified Body audits, implementing corrective actions as needed.
• Engage in governance activities across multiple divisions and functions globally.

Requirements

• Expert understanding of medical device regulations and industry standards globally.
• Expert knowledge of worldwide medical device legislation and regulations.
• Deep understanding of product quality specifications and quality control methods.
• Extensive experience interacting with Health Authorities and Notified Bodies.
• Extensive knowledge in Pharmacovigilance and medical device regulations.
• Strong leadership and communication skills, with networking ability.
• Excellent analytical thinking with a high sense of responsibility and accountability.
• Fluency in English.

Nice-to-haves

• Master's degree in engineering or Life-science Discipline with 6 years of medical device industry experience.
• Bachelor's Degree in Engineering or Life-science Discipline with 8 years of medical device industry experience, including 4 years in quality management systems.