Senior PSUR Writer

CooperSurgical; Trumbull (CT); Remoto; USD 100.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical coverage

401(k)

Parental leave

Fertility benefits

Paid time off

Descrizione del lavoro

CooperSurgical is seeking a Sr. PSUR Writer to lead development, review, and submission readiness of PSURs, PMSPs, and PMSRs across global medical device portfolios.

This role requires deep knowledge of post-market surveillance and regulatory requirements, with ability to mentor junior writers and support global teams. You will collaborate with Regulatory Affairs, Quality Assurance, Clinical Affairs, and Risk Management to ensure timely compliance with EU MDR, FDA, ISO standards, and to drive

Competenze

• 5+ years in Medical Writing, Regulatory Affairs, Post-Market Surveillance, Pharmacovigilance, Clinical Affairs, or Quality Assurance within the medical device industry.
• 3+ years authoring PSURs, PMSRs, PMS Plans, CERs, or equivalent regulatory documentation.
• Experience independently leading complex regulatory writing projects.

Mansioni

• 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 PMS/PSUR.
• Establish and maintain standardized authoring templates to ensure consistency, quality, and compliance.
• Identify gaps in PMS processes and drive process improvement initiatives.
• Provide training and guidance to cross-functional stakeholders on PSUR processes and documentation requirements.
• Partner with Regulatory Affairs, Quality Assurance, Clinical Affairs, and Risk Management to implement best practices.
• Mentor and provide technical guidance to junior PSUR writers.
• 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.

Conoscenze

PSUR writing

Regulatory writing

Post-market surveillance

EU MDR 2017/745

FDA regulations

Risk management

Mentoring

Cross-functional leadership

Formazione

Bachelor's degree

Advanced degree preferred

Strumenti

Microsoft Office

Document management systems

Descrizione del lavoro

JOB DESCRIPTION

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.

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 Period 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.

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 Period 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/or international travel.

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.

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 $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.