Responsibilities:

• Facilitating business data collection, reporting efforts, and generating periodic product PSUR / post market surveillance reports.
• Use local and global systems to collect various post market information such as complaint, field corrective action and CAPA data.
• Work with subject matter experts to analysed product related data and document conclusions of the review activities.
• Analysis of post market data and reviewing completed reports with business partners.
• Maintaining and supporting databases and systems used for tracking various quality management system (QMS) activities related to post market surveillance.
• Maintain, archive and completed controlled quality records.
• Coordinate PMS and post market performance follow-up (PMPF) deliverables with internal business partners.
• Facilitate and/or chair local/regional PMS Board meetings.
• Support various QMS and PMS projects (local and global) as needed.
• Support internal/external audits as needed.
• Perform other related duties and assignments as needed.

Requirements:

• Bachelor’s degree or equivalent in a related life science/technical/engineering discipline or equivalent preferred.
• 5+ years of experience in a regulated manufacturing industry or equivalent combination of education and experience.
• Understanding of GMP and quality system standards.
• Facilitation and generation of product Post Market Surveillance (PMS) and PSUR reports.
• Analysis of post market data understanding of product post market surveillance requirements for IVD products a plus.
• Working knowledge of device/drug/biotech manufacturing processes.
• Advanced technical writing and word processing skills.
• Experience with electronic systems (i.e., Veeva, etc., Track Wise).

• Facilitating business data collection, reporting efforts, and generating periodic product PSUR / post market surveillance reports.
• Use local and global systems to collect various post market information such as complaint, field corrective action and CAPA data.
• Work with subject matter experts to analysed product related data and document conclusions of the review activities.
• Analysis of post market data and reviewing completed reports with business partners.
• Maintaining and supporting databases and systems used for tracking various quality management system (QMS) activities related to post market surveillance.
• Maintain, archive and completed controlled quality records.
• Coordinate PMS and post market performance follow-up (PMPF) deliverables with internal business partners.
• Facilitate and/or chair local/regional PMS Board meetings.
• Support various QMS and PMS projects (local and global) as needed.
• Support internal/external audits as needed.
• Perform other related duties and assignments as needed