PSUR Writer II

CooperCompanies; United States; Remote; USD 75,000 - 100,000; Full time

Job summary

CooperSurgical is seeking a PSUR Writer II to prepare and maintain Post-Market Surveillance Plans, Reports, and Periodic Safety Update Reports to meet global regulatory requirements. The role collaborates across functions to gather safety and clinical data, evaluates information, and ensures timely, compliant documentation.

The position emphasizes strong written communication, regulatory knowledge (EU MDR, FDA), and proficiency with MS Word/Excel/Teams/SharePoint, with responsibilities spanning

Qualifications

• Bachelor's degree in a scientific, technical, healthcare, or related discipline.

Responsibilities

• Prepare, maintain and timely complete PMSPs, PMSRs, and PSURs to ensure regulatory compliance.
• Collaborate cross-functionally to gather safety, clinical, complaint, vigilance and risk management information.
• Evaluate and summarize data and ensure documentation aligns with regulatory requirements and internal timelines.
• Contribute to process improvements and support development of procedures and templates for post-market surveillance.

Education

Bachelor's degree in scientific/technical field

Tools

Microsoft Word

Microsoft Excel

Microsoft Teams

SharePoint

Job description

About CooperSurgical

CooperSurgical is a leading fertility and women’s 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, we're driven by a unified purpose to enable patients to experience life's 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 women’s 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 www.coopersurgical.com .

Work location: Remote in US

Job Summary:

The PSUR Writer II is responsible for the preparation, maintenance, and timely completion of Post-Market Surveillance Plans (PMSPs), Post-Market Surveillance Reports (PMSRs), and Periodic Safety Update Reports (PSURs) to ensure compliance with global regulatory requirements. The role collaborates cross-functionally to gather relevant safety, clinical, complaint, vigilance, and risk management information; evaluates and summarizes data; and ensures documentation is completed in accordance with applicable regulatory requirements and internal timelines. The PSUR Writer II contributes to process improvements, supports the development of departmental procedures and templates, and serves as a knowledgeable resource for post-market surveillance documentation activities.

Knowledge, Skills and Abilities:

• Strong written and verbal communication skills.
• Basic understanding of EU MDR, FDA regulations, and medical device vigilance requirements.
• Ability to summarize technical and scientific information clearly.
• Strong organizational and time-management skills.
• Detail-oriented with strong document review capabilities.
• Proficiency with Microsoft Word, Excel, Teams, and SharePoint.
• Basic understanding of Quality Management Systems.
• Ability to work effectively in a cross-functional team environment.

Work Environment:

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

Experience:

• 3+ years experience in Quality Assurance, Regulatory Affairs, Pharmacovigilance, Medical Writing, or related medical device functions.
• Experience supporting PMS Plans, PSURs, PMSRs, CERs, or related regulatory documents preferred.

Education:

• Bachelor's degree required in a scientific, technical, engineering, healthcare, or related discipline.

Our Benefits:

As an employee of CooperSurgical, you'll 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 at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

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 pay for this role is between $75,000.00 - $100,000.00 annually. The actual base pay includes 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.