Sr Specialist Vigilance and QARA
Insulet(3 months ago)
About this role
A Post-Market Surveillance and Regulatory Affairs specialist responsible for reviewing, analyzing, and responding to regulatory agencies regarding medical device reportable events. The role manages internal and external communications for post-market surveillance and collaborates across quality, clinical, customer care, and regulatory teams to ensure compliance and proper documentation. It also supports vigilance and regulatory topics and performs regulatory review of materials for third parties.
Required Skills
- Regulatory Reporting
- Postmarket Surveillance
- Complaint Analysis
- Complaint Handling
- Investigation
- Communication
- Technical Writing
- Auditing
- Salesforce
- Microsoft Excel
+5 more
Qualifications
- BA/BS Degree
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