Senior PSUR & Post-Market Surveillance Lead

CooperSurgical; Trumbull (CT); Remote; USD 100,000 - 130,000; Full time

Benefits offered by this job

Medical coverage

401(k)

Parental leave

Fertility benefits

Paid time off

Job summary

CooperSurgical is seeking a Sr. PSUR Writer to lead development, review, and submission readiness of PSURs, PMSPs, and PMSRs across global medical device portfolios.

This role requires deep knowledge of post-market surveillance and regulatory requirements, with ability to mentor junior writers and support global teams. You will collaborate with Regulatory Affairs, Quality Assurance, Clinical Affairs, and Risk Management to ensure timely compliance with EU MDR, FDA, ISO standards, and to drive

Qualifications

• 5+ years in Medical Writing, Regulatory Affairs, Post-Market Surveillance, Pharmacovigilance, Clinical Affairs, or Quality Assurance within the medical device industry.
• 3+ years authoring PSURs, PMSRs, PMS Plans, CERs, or equivalent regulatory documentation.
• Experience independently leading complex regulatory writing projects.

Responsibilities

• Lead the authoring, review, and maintenance of PSURs, PMSPs, PMSRs, and related post-market surveillance documentation.
• Independently manage multiple product families and report cycles simultaneously.
• Interpret and analyze complaint, vigilance, clinical, literature, CAPA, trend, and risk management data to support safety assessments.
• Develop comprehensive safety narratives, conclusions, and risk-benefit evaluations.
• Serve as the primary cross-functional liaison for PSUR development activities.
• Ensure compliance with EU MDR 2017/745, FDA requirements, ISO 13485, and ISO 14971 expectations.
• Identify safety signals, emerging trends, and potential regulatory risks.
• Provide recommendations regarding risk management file updates and surveillance strategies.
• Lead the development, implementation, and maintenance of global procedures, work instructions, templates, and best practices related to PMS/PSUR.
• Establish and maintain standardized authoring templates to ensure consistency, quality, and compliance.
• Identify gaps in PMS processes and drive process improvement initiatives.
• Provide training and guidance to cross-functional stakeholders on PSUR processes and documentation requirements.
• Partner with Regulatory Affairs, Quality Assurance, Clinical Affairs, and Risk Management to implement best practices.
• Mentor and provide technical guidance to junior PSUR writers.
• Lead process improvement initiatives related to PMS and PSUR development.
• Support regulatory inspections, audits, and responses related to PMS documentation.
• Present findings and status updates to management and cross-functional stakeholders.
• Escalate significant compliance risks, resource concerns, and timeline impacts.
• Perform other duties as assigned.

Skills

PSUR writing

Regulatory writing

Post-market surveillance

EU MDR 2017/745

FDA regulations

Risk management

Mentoring

Cross-functional leadership

Education

Bachelor's degree

Advanced degree preferred

Tools

Microsoft Office

Document management systems

Job description

CooperSurgical is seeking a Sr. PSUR Writer to lead development, review, and submission readiness of PSURs, PMSPs, and PMSRs across global medical device portfolios.

This role requires deep knowledge of post-market surveillance and regulatory requirements, with ability to mentor junior writers and support global teams. You will collaborate with Regulatory Affairs, Quality Assurance, Clinical Affairs, and Risk Management to ensure timely compliance with EU MDR, FDA, ISO standards, and to drive