PSUR Writer II

This is a fully remote position, open to applicants in Connecticut.

📋 Description

• Create and uphold PMS documentation, including PMSPs, PMSRs, and PSURs for designated product portfolios.

• Collect and consolidate information from Clinical Affairs, Regulatory Affairs, Risk Management, Marketing, Quality, and other relevant stakeholders.

• Evaluate and summarize post-market surveillance, complaint, vigilance, clinical, and risk management data to formulate regulatory-compliant safety summaries and trend analyses.

• Assist in literature reviews and post-market surveillance initiatives.

• Execute public database searches for adverse events, recalls, and competitor safety information.

• Conduct data collection, quality checks, and basic analyses to aid in PSUR development.

• Review, trend, and analyze pertinent safety and performance data to support conclusions presented within PMSRs and PSURs.

• Maintain documentation within the Quality Management System.

• Identify potential risks related to timelines, quality, or data affecting assigned reports and communicate mitigation strategies to management.

• Contribute to the creation, upkeep, and continuous enhancement of PMS and PSUR-related procedures, work instructions, templates, and guidance documents.

• Recognize opportunities to enhance document quality, consistency, and efficiency within PMS reporting workflows.

• Ensure documentation is kept in line with Quality Management System requirements and current regulatory standards.

• Support EU MDR compliance activities concerning PMS documentation.

• Engage in cross-functional meetings and project discussions.

• Execute other duties as assigned.

⛳️ Requirements

• Excellent written and verbal communication abilities.

• Fundamental understanding of EU MDR, FDA regulations, and medical device vigilance requirements.

• Capability to clearly summarize technical and scientific information.

• Strong organizational and time-management skills.

• Detail-oriented with proficient document review skills.

• Proficiency in Microsoft Word, Excel, Teams, and SharePoint.

• Basic knowledge of Quality Management Systems.

• Ability to collaborate effectively in a cross-functional team setting.

• A minimum of 3 years of experience in Quality Assurance, Regulatory Affairs, Pharmacovigilance, Medical Writing, or related fields in the medical device industry.

• Experience supporting PMS Plans, PSURs, PMSRs, CERs, or similar regulatory documents is preferred.

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

• Ability to sit for extended periods, particularly in front of a computer.

• This position may necessitate 0-5% domestic and/or international travel.

🏝️ Benefits

• Medical coverage.

• 401(k).

• Parental leave.

• Fertility benefits.

• Paid time off for vacation, personal, sick, and holidays.

• Multiple additional perks and benefits.

• Potential eligibility for other forms of compensation and benefits.