PSUR Writer II (Medical Devices)

Location: Remote in the United States; based at the Trumbull, Connecticut site, with 0–5% domestic and international travel possible.

Salary: $75,000–$100,000 annual base pay.

Company

hirify.global is a fertility and women’s healthcare company offering medical devices, testing and treatment solutions, assisted reproductive technology, and genomic testing products.

What you will do

• Author and maintain Post-Market Surveillance Plans, Post-Market Surveillance Reports, and Periodic Safety Update Reports for assigned product portfolios.
• Gather information from Clinical Affairs, Regulatory Affairs, Risk Management, Marketing, Quality, and other stakeholders.
• Analyze post-market surveillance, complaint, vigilance, clinical, and risk management data to prepare safety summaries and trend analyses.
• Support literature reviews, public database searches, adverse-event and recall research, and post-market surveillance activities.
• Maintain documentation in the Quality Management System and identify timeline, quality, and data risks.
• Improve PMS and PSUR procedures, work instructions, templates, guidance documents, and reporting efficiency.

Requirements

• At least 3 years of experience in Quality Assurance, Regulatory Affairs, Pharmacovigilance, Medical Writing, or related medical device functions.
• Bachelor’s degree in a scientific, technical, engineering, healthcare, or related discipline.
• Basic understanding of EU MDR, FDA regulations, medical device vigilance, and Quality Management Systems.
• Experience supporting PMS Plans, PSURs, PMSRs, CERs, or related regulatory documents is preferred.
• Strong written and verbal communication, organization, time management, and document review skills.
• Proficiency with Microsoft Word, Excel, Teams, and SharePoint.

Nice to have

• Experience with post-market surveillance plans and regulatory safety documentation.
• Experience with medical device clinical evaluation reports.

Culture & Benefits

• Remote work within the United States.
• Medical coverage, 401(k), paid vacation, personal, sick, and holiday time.
• Parental leave and fertility benefits.
• Additional compensation and employee benefits may be available.