Senior PSUR Writer

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 Periodic 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.

Qualifications

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.