Sr. Specialist, Post Market Surveillance
Current• Establish and lead cross-functional teams to conduct product recalls (FCAs). Facilitates team decision making, development of recall strategy and communications. Monitors recall progress and measures communication and corrective action effectiveness. Summarizes recall actions and assembles required records for recall files and related CAPAs.• Collaborates with Regulatory, Clinical, Medical Affairs and Marketing with collection and analysis of proactive post-market surveillance data (surveys, web-site searches, literature reviews, etc.). Maintains records of data and conclusions of evaluations.• Interprets current regulations, standards, and guidance to execute new policies or modify existing written procedures to meet domestic and international requirements. • Oversees complaint/pMDR/MDR investigations and submission of Medical Device Reports and Mandatory Problem Reports to the FDA and Health Canada respectively.• Collaborate on the development of Health Hazard Evaluations for FDA and/or Health Canada reportable events, as applicable.• Ensures quality metrics in areas of responsibility are achieved and systemic trends are addressed. Tracks and analyses key success indicators, trending and reporting metrics that effectively measure and communicate quality performance and team productivity to established objectives.• Manages processes in Quality System include writing, reviewing and approval of Corporate Operating and Standard Operating procedures, Subject Matter Expert in internal and external audits, supporting continuous improvement initiatives.
