Lead Vigilance and QARA Spain
Insulet(3 months ago)
About this role
The role supports post-market vigilance for Insulet’s medical device platform by reviewing, analyzing and composing responses to regulatory agencies for reportable events. The position collaborates across functions (quality, clinical, customer care and regulatory) to ensure compliance with EU and country-specific vigilance requirements and serves as the local regulatory contact for Spain. The role reports to the Director EMEA Vigilance and QARA.
Required Skills
- Vigilance Reporting
- Complaint Processing
- Technical Writing
- Regulatory Compliance
- Postmarket Surveillance
- Data Interpretation
- Stakeholder Liaison
- Audit Support
- Spanish Fluency
- English Fluency
Qualifications
- BA/BS Degree
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