Post Market Surveillance Adverse Event Analyst

Intuitive-posted about 1 year ago
$90,200 - $129,800/Yr
Full-time • Mid Level
Peachtree Corners, GA
Miscellaneous Manufacturing
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The Regulatory Post Market Surveillance Adverse Event Analyst at Intuitive Surgical is responsible for investigating customer complaints related to serious injuries, adverse events, or deaths associated with medical devices. This role involves making reporting decisions, filing regulatory reports, and ensuring the completeness and consistency of complaint documentation. The analyst will engage in live telephone intake of adverse events, conduct thorough investigations, and collaborate with various internal teams to ensure compliance with regulatory requirements.

  • Investigating serious injury/adverse event and death complaints daily
  • Perform the preliminary classification of complaints including reportability triage and decision making
  • Conduct complaint investigations including following up with surgeons and other health care professionals via phone and email
  • Answer live, incoming phone calls for Adverse Events from Customer Service, Technical Service, Intuitive Representatives and hospital site contacts
  • Collect in-depth information and document complaints into the CRM system
  • Perform reportability determinations in conjunction with medical safety officer
  • Provide input to clinical conclusions to be included in complaint files and regulatory reports
  • Escalate complaints that require additional review to relevant departments
  • Accurately select Risk (Hazard, Harms, Severity) and IMDRF codes
  • Review product analysis investigations and determine cause/contribution of events to devices
  • Draft and file medical device and vigilance reports
  • Evaluate documentation for completeness and consistency
  • Approve final complaint files for closure after all applicable actions are completed
  • Manage complaint workload to required timeliness and goals
  • Collaborate with internal teams to provide relevant clinical information related to adverse events
  • Adhere to standard operating procedures and guidance documents for reporting and compliance
  • Analyze complaint data to identify trends and issues
  • Recognize and escalate trends and safety concerns to defined escalation paths
  • Provide the risk management team with required data for risk management files
  • Collaborate with the Medical Safety Office and Legal Department as needed
  • Ensure compliance with post market surveillance processes
  • Assess product relationships to reported complaints
  • Complete responses for Regulatory Agency Requests for additional information
  • Represent Post Market Surveillance at selected cross-functional meetings
  • Provide reporting of key metrics and action plans
  • Drive the progress of complaints throughout the lifecycle to ensure proper documentation and timely closure
  • Participate in internal and external audits
  • Develop and maintain product knowledge of existing and new products
  • Maintain awareness of new or revised regulations and guidelines
  • Provide peer review and feedback of complaints and reports
  • Participate in new hire training and continuous Regulatory Compliance training
  • Participate in process improvement activities
  • Execute on projects as required
  • Minimum undergraduate degree, preferably in life science (e.g. RN, engineering)
  • Minimum 5+ years of experience in the medical device field
  • Working knowledge of 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
  • Strong written and verbal communication skills
  • Strong computer skills (Excel, Word, PowerPoint, database query)
  • Efficient independent worker with ability to focus
  • Attention to detail
  • Cross-functional communication skills
  • Customer service based phone communication skills
  • Strong analytical and organizational skills
  • Ability to handle and manage workload independently
  • Prioritize/multi-task numerous activities in a rapid-paced environment
  • Strong interpersonal and decision-making skills
  • Market-competitive compensation packages
  • Base salary range of $76,700 - $129,800
  • Incentives and benefits
  • Equity opportunities
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