About the role

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 .
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.
Originally posted on Himalayas

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Senior

Technology & IT Remote Collaboration Writing Senior Psur Writer Senior level

Likely questions

Tell us about work you have done that is close to the Senior PSUR Writer role.
How would you approach your first 30 days at CooperCompanies?
Which of Remote Collaboration, Writing and Senior have you used recently, and what did it help you achieve?
How have you led people, improved a process, or made a hard decision in a previous role?
How do you handle busy days, changing priorities, or pressure at work?

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A recent example that proves your experience with Remote Collaboration, Writing and Senior.
One short story with a problem, your action, and the result.
Two examples that show the strengths listed on your CV.
A clear reason why this role and company interest you.
Your availability, preferred work style, and salary expectations.

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What would success look like in the first 90 days?
What are the main problems this hire should help solve?
How does the team give feedback and measure good work?
What does a normal working week look like for this role?

Practice line

I am interested in the Senior PSUR Writer role because I can bring practical experience in Remote Collaboration, Writing and Senior, learn the team quickly, and contribute to the outcomes CooperCompanies needs from this hire.

Senior PSUR Writer

About the role

Walk in with sharper answers.

Likely questions

Prepare before the call

Ask them

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