About this 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 www.coopersurgical.com .
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.
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 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.
Education:
- Bachelor's 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, 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.
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 place. 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 pay for this role is between $100,000.00 - $130,000.00 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.