Senior PSUR & Regulatory Safety Lead (Remote)

CooperSurgical, Inc. in; Trumbull (CT); Remote; USD 110,000 - 160,000; Full time

Job summary

CooperSurgical is seeking a Sr. PSUR Writer to lead the development, review, and submission readiness of Post-Market Surveillance Plans (PMSPs), Post-Market Surveillance Reports (PMSRs), and Periodic Safety Update Reports (PSURs) for global medical device portfolios.

This regulatory expert will interpret safety data, provide risk-benefit evaluations, and mentor junior writers while ensuring timely, compliant documentation from a remote US location.

Job description

CooperSurgical is seeking a Sr. PSUR Writer to lead the development, review, and submission readiness of Post-Market Surveillance Plans (PMSPs), Post-Market Surveillance Reports (PMSRs), and Periodic Safety Update Reports (PSURs) for global medical device portfolios.

This regulatory expert will interpret safety data, provide risk-benefit evaluations, and mentor junior writers while ensuring timely, compliant documentation from a remote US location.