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On behalf of our client a leading manufacturing medical device company. We are seeking for a candidate that will be a part of the global PSUR Reporting Team. Candidate will be facilitating business data collection, reporting efforts and generating periodic product PSUR / post market surveillance reports. This includes regular interactions with area subject matter experts to ensure data is collected, documented, and analyzed.

Job Responsibilities:
· Facilitation and generation of product Post Market Surveillance (PMS) and PSUR reports.
· Use local and global systems to collect various post market information such as complaint, field corrective action and CAPA data.
· 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.

Education and Experience:
· Bachelor's degree or equivalent in a related life science/technical/engineering discipline or equivalent preferred.
· 5+ years' experience in a regulated manufacturing industry or equivalent combination of education and experience.
· Understanding of GMP and quality system standards.
· Understanding of product post market surveillance requirements for IVD products a plus.
· Working knowledge of device/drug/biotech manufacturing processes.
· Experience with electronic QMS systems (i.e. Veeva, EtQ, Trackwise) a plus.