Anila Kale
Regulatory Affairs Manager at Medtronic
- Role
- Regulatory Affairs Manager at Medtronic
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Anila Kale
Pre-market and post-market submissions for high-risk devices.• Prequalification of in-vitro diagnostics products with the World Health Organization.• Change assessment for reportability.• Preparation and review of technical files to get medical devices CE marked in the EU and updates to technical files.• Working in ISO 13485:2003 quality management system-compliant environments. • Drug and medical device regulations for North America.
Experience
Regulatory Affairs Manager
Jul 2025 — Present
Education
Long Island University
MS, Pharmacy - Drug Regulatory Affairs
2010 — 2012
Skills
- Diagnostics
- Technical Files
- Medical Devices
- In Vitro
- Regulatory Affairs
- Ce Marking
- 510 K
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