Regulatory affairs specialist (Vantive)
6/2/20261 min read
Roles and Responsibilities
Job Description:
1. Identify Regulatory strategy and support sustaining projects for Digital portfolio
2. Prepare Regulatory dossiers for EU & US
3. Provide submission deliverables for GeoX submissions
4. Plan Regulatory activities for EU MDD and MDR compliance
5. Obtain Regulatory Clearances in Target countries
6. Coordinate with Regulatory Authorities and respond to any questions/deficiencies/clarification for products that are submitted for approval
7. Coordinate with in-Country RAs for submissions/Registrations, Renewals, EOL
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