Mohan Umale

Regulatory & Quality Compliance Professional - ASPAC Region

Role
Head - Quality & Regulatory Compliance (Aspac Region) at QuidelOrtho
Location
Mumbai, MH, IN
LinkedIn followers
500 followers
Manufacturing & ProductionView LinkedIn profile

About Mohan Umale

Professional with good knowledge and experience in regulatory Affairs, clinical trial…

Experience

  1. Head - Quality & Regulatory Compliance (Aspac Region)

    QuidelOrtho

    Apr 2023 — Present · Mumbai, IN

Education

  • College of Pahrmacy Solapur

    Bachelor's Degree, Bachelors of Pharmacy

    2001

  • Manipal Academy of Higher Education

    Master's Degree, Masters in Pharmacy

    2004 — 2006

Skills

  • Auditing
  • Iso 14971
  • Ce Marking
  • Due Diligence
  • Healthcare
  • Qsr
  • Pharmaceutical Industry
  • Sop
  • Fda
  • Drug Safety
  • Regulatory Strategy Development
  • Pharmaceutical Law
  • Pharmacovigilance
  • Strategic Planning
  • Standard Operating Procedure (Sop)
  • Regulatory Affairs
  • Design Control
  • New Product Implementations
  • Corrective and Preventive Action (Capa)
  • Risk Management
  • Quality System
  • Medical Devices
  • Clinical Research
  • Capa
  • Complaint Management
  • Regulatory Requirements
  • Iso 13485
  • Post Market Surveillance
  • Gcp
  • Clinical Trials
  • Ectd
  • Compliance
  • Regulatory Submissions
  • Policy Analysis
  • U.s. Food and Drug Administration (Fda)
  • Medical Diagnostics
  • Complaint Handling System - Medical Device
  • Clinical Development
  • Asian Markets
  • Quality Management

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Mohan Umale — Head - Quality & Regulatory Compliance (Aspac Region) at QuidelOrtho in Mumbai, MH, IN | Unifers