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Senior Post Market Surveillance Specialist
Job Purpose Summary As a Sr Post Market Surveillance Specialist, you will ensure customer complaints are reviewed, evaluated, investigated, documented and closed in a timely manner to ensure compliance with applicable Global Regulatory requirements. What you will do • Support all post market compliance activities including handling of customer complaints, adverse event reporting and medical device reports • Perform preliminary investigation of complaints, including follow up with healthcare professionals • Initiate, complete, and submit adverse event reports in an accurate and timely manner to the appropriate regulatory authorities within the required timeframe per applicable geography regulations. • Use product and process knowledge to escalate complaints to the Engineering and Supply Chain teams for product support • Compiles assigned complaint investigation and failure analysis information into an investigation report, documents root cause, applies event codes and routes complaint investigation reports for approvals per established timelines. • Communicate effectively with internal and external customers on the outcome of complaints and adverse event investigations • Drives complaints investigation, progress, reporting timeliness and determines closure • Collaborates with Supply Chain, Engineering, Product Design, Commercial, and other support areas to obtain/provide information related to complaint investigations, customer feedback, and other aspects of complaint handling • Applies knowledge of medical device regulatory requirements in order to support the MDR reporting process and identifying reportable events as they are received. • Communicate effectively with internal and external customers on the outcome of complaints and adverse event investigations • Keeps organization abreast of customer complaints and adverse events trends and escalates appropriately • Participates in new hire training and continuous Regulatory Compliance training as required • Participates in process improvement activities to continuously improve process effectiveness What you will need (job requirements) • Bachelor’s degree in Life Sciences/related field or equivalent work experience • 5+ years of experience working in a medical device industry • 1+ years or experience in managing, processing and closing product complaints • Working knowledge and understanding of the FDA 21 CFR part 803 Medical Device Reporting and part 820.198 for Complaint File management • Global regulatory medical device requirements for EU, MDSAP countries, and other related requirements. • Ability to manage real-time customer feedback and process information to provide primary product support or resolve simple inquiries. • Understands clinical settings enough to engage a conversation with clinicians related to product characteristics. • Ability to analyze information and derive root cause or preliminary conclusions related to product perceived or confirmed failures. • Firm understanding of regulatory reporting requirements for medical device reporting. • Firm understanding of quality systems regulations, specifically good documentation practices. Apply tot his job
