Senior PSUR Writer

CooperCompanies•Trumbull, CT

3d•Remote

About The Position

The Sr. PSUR Writer is responsible for leading 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 role serves as a subject matter expert in post-market surveillance documentation and regulatory requirements, provides strategic input regarding safety trends and risk-benefit evaluations, and supports junior writers while ensuring timely compliance with domestic and international regulations.

Requirements

Advanced knowledge of EU MDR 2017/745, FDA regulations, ISO 13485, ISO 14971, and post-market surveillance requirements.
Strong scientific and technical writing abilities.
Ability to independently interpret complex safety, clinical, and quality data.
Strong project leadership and stakeholder management skills.
Excellent analytical, critical-thinking, and problem-solving capabilities.
Experience leading cross-functional initiatives.
Advanced proficiency in Microsoft Office applications and document management systems.
Strong understanding of medical device risk management principles and post-market surveillance processes.
Ability to mentor and train junior team members.
5+ years experience in Medical Writing, Regulatory Affairs, Post-Market Surveillance, Pharmacovigilance, Clinical Affairs, or Quality Assurance within the medical device industry.
3+ years experience authoring PSURs, PMSRs, PMS Plans, CERs, or equivalent regulatory documentation.
Experience independently leading complex regulatory writing projects.
Bachelor's degree required in a scientific, technical, engineering, healthcare, or related discipline.

Nice To Haves

Advanced degree preferred.

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 Post-Market Surveillance Plans (PMSPs), Post-Market Surveillance Reports (PMSRs), and Periodic Safety Update Reports (PSURs).
Establish and maintain standardized authoring templates to ensure consistency, quality, and compliance across product portfolios.
Identify gaps in PMS processes and drive process improvement initiatives to enhance efficiency, inspection readiness, and regulatory compliance.
Provide training and guidance to cross-functional stakeholders on PSUR processes, procedures, and documentation requirements.
Partner with Regulatory Affairs, Quality Assurance, Clinical Affairs, and Risk Management to develop and implement best practices for PMS documentation lifecycle management.
Mentor and provide technical guidance to junior PSUR writers and other team members.
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.