Technical Writer – Post-Market Surveillance

Technical Writer – Post-Market Surveillance

Requirements

• Bachelor’s degree in Science, Engineering, or a healthcare-related field.
• Minimum of 5 – 8 years of experience in post-market surveillance or quality assurance in the medical device industry or related field.
• Proficiency in regulations for In-Vitro Diagnostic Regulation (2017/746) and Health Canada regulations
• Excellent technical writing skills, analytical skills, and ability to communicate and present technical information.
• Understanding of QSR & ISO requirements.

Responsibilities

• Create and maintain the Diagnostics and Perinatal global PMS documentation (PMS Reports (PMSR), Periodic Safety Update Reports (PSUR)) for European IVDR, Great Britain, and Health Canada Summary Reports, or any future PMS requirements.
• Ensure timely completion and compliance with applicable regulatory requirements.
• Collect global PMS data from complaints, CAPAs, sales, reportable events, and trends for each product.
• Analyze global post market data for each product including complaint trend analysis, volume of sales and rates, recalls and incident reporting
• Assess trends by reason, severity, and lots in the PMS reports.
• Assess and submit a trend report for any statistically significant increase in the frequency or severity of non- incidents.
• Review recalls, serious incidents, and CAPAs for each product and determine inclusion / exclusion decisions.
• Perform public adverse events and recall database searches for subject and similar devices.
• Analyze adverse events and recall database search results for applicability to subject and/or similar device for inclusion/exclusion decision.
• Evaluate PMS reports by each product for updates to the risk-benefit determination and to determine if any additional activities are required for improving the design, manufacturability, or product labeling.
• Summarize collected and analyzed PMS data in a report using technical knowledge and ensuring high quality and compliance of report content.
• Submit PMS documentation in agile for approval.
• Maintain updates to the PMS procedures and templates as needed.
• Maintain an understanding of global medical device regulations in relation to Post Market Surveillance and recognize and implement enhancements as needed.
• Maintain a working knowledge of Hologic products this position supports.
• Interacts/coordinates with and supports other departments and SMEs as needed.
• Communicate results and conclusions from sustaining reports to stakeholders.
• Assist in audits and additional QA duties as assigned.
• Perform other function-related activities in addition to the above-mentioned responsibilities as reasonably required by business needs.

Preferred Qualifications

• Prior experience of processing medical device or drug complaints, CAPAs, and reportable events preferred.