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 Now
Apply Now
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 Now
Apply Now