Komal Karia
Regulatory Affairs Specialist | Post market surveillance | IVDRs | Adverse event reporting | Post market Quality Clinical specialist
- Role
- Senior Regulatory Affairs Specialist at Solventum
- Location
- Atlanta, GA, US
- LinkedIn followers
- 500 followers
About Komal Karia
As a Regulatory Affairs Specialist at Abbott, my expertise lies in navigating complex…
Experience
Senior Regulatory Affairs Specialist
Jan 2025 — Present
Responsible for the preparation and compiling of document packages for regulatory submissions,audits and inspections. Participate in technical review of data or reports that will be incorporated.• Manage and maintain regulatory databases and technical files.• Participate in internal and external audits.• Reviews materials such as labelling, marketing materials or user manuals to ensure compliance withregulatory agency requirements and laws• Manage labelling and UDI requirements. Recommends changes for labelling, manufacturing, marketing and clinical protocols for regulatory compliance.• Writing STED for EUMDR submission and working with cross functional teams to makeour products MDR compliant.• Review regulatory documentation for various FDA submissions. Determined regional labelling requirements reviewed and approving final labelling and packaging.• Assisted in generating technical documents for technical file and ECR changes. Maintaining Design History Files, STED documents and creating new files for missing dataand tracking all deliverables
Education
UC Irvine
Regulatory affairs and compliance
2021 — 2022
Gujarat University
Master's degree
2011 — 2013
Saurashtra University
Bachelor's degree
2007 — 2011
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