Medical Safety Manager, Ambulatory Monitoring & Diagnostics

About the role

Works independently on safety evaluations and risk management for medical devices, with at least three days a week in the office when not at customer or supplier sites.

At a glance

What you will do

• Run safety evaluations using post-market surveillance, literature and trial data to spot risks and signals
• Give safety input on health hazard evaluations, risk-benefit analyses and recalls
• Support new product launches, clinical studies and regulatory submissions with safety documentation
• Answer safety questions from clinicians, patients and colleagues, and help keep safety policies current
• Track changes in medical device safety rules and feed them into study design and vigilance work

What they look for

• Five or more years in medical affairs, clinical affairs or medical safety with a bachelor's degree, or three or more with a master's or high
• Prior hands-on clinical experience at the bedside
• Working knowledge of medical device standards and regulations such as ISO and IEC
• Bachelor's or master's in medical science, nursing or similar; MD or PhD strongly preferred
• Certified Professional in Patient Safety preferred