Senior PSUR Writer

About CooperSurgical

CooperSurgical is a leading fertility and womens healthcare company dedicated to putting time on the side of women babies and families at the healthcare moments that matter most in life. As a division of CooperCompanies were driven by a unified purpose to enable patients to experience lifes beautiful moments. Guided by our shared values dedicated innovative friendly partners and do the right thing our offerings support patients throughout their lifetimes from contraception to fertility and birth solutions to womens and family care and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers including testing and treatment options as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at.

Work location: Remote in US

Job Summary:

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.

• 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.

Travel:

This position may require 0-5% domestic and/orinternationaltravel.

Knowledge Skills and Abilities:

• 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.

Work Environment:

• Prolonged periods of sitting especially in front of a computer.

Experience:

• 5 years experience inMedical 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.

Education:

• Bachelors degree required in a scientific technical engineering healthcare or related discipline.
• Advanced degree preferred.

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Our Benefits:

As an employee of CooperSurgical youll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck we offer a great compensation package medical coverage 401(k) parental leave fertility benefits paid time off for vacation personal sick and holidays and multiple other perks and benefits. Please visit us atto learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email the internet or in any form and/or method will be deemed the sole property of CooperSurgical unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race color ancestry religion sex national origin sexual orientation age citizenship marital status disability gender gender identity or expression or veteran status. We are proud to be an equal opportunity workplace.

For U.S. locations that require disclosure of compensation the starting base payfor this role is between$100000.00 - $130000.00 annually. Theactual base payincludes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.