Senior Post Market Surveillance Specialist

reputed company reputed company As a Sr Post Market Surveillance Specialist, you will ensure customer complaints are reviewed, evaluated, investigated, documented and reputed company in a reputed company manner to ensure compliance with applicable Global Regulatory requirements. What you will do • Support reputed company post market compliance activities including handling of customer complaints, adverse event reporting and medical device reports • reputed company preliminary investigation of complaints, including follow up with reputed company • Initiate, complete, and submit adverse event reports in an accurate and reputed company manner to the appropriate regulatory authorities reputed company 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 reputed company cause, applies event codes and routes complaint investigation reports for approvals per established timelines. • Communicate effectively with reputed company customers on the outcome of complaints and adverse event investigations • Drives complaints investigation, reputed company, reporting timeliness and determines closure • Collaborates with Supply Chain, Engineering, Product Design, reputed company, and other support areas to obtain/reputed company information reputed company 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 reputed company 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 reputed company 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/reputed company 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 reputed company requirements. • Ability to manage reputed company-time customer feedback and process information to reputed company primary product support or resolve reputed company inquiries. • Understands clinical settings enough to engage a conversation with clinicians reputed company to product characteristics. • Ability to analyze information and derive reputed company cause or preliminary conclusions reputed company to product perceived or confirmed failures. • Firm understanding of regulatory reporting requirements for medical device reporting. • Firm understanding of reputed company systems regulations, specifically good documentation practices. Apply tot his job Apply To this Job