Regulatory Affairs Specialist Job at Indotronix Avani Group, Irvine, CA

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  • Indotronix Avani Group
  • Irvine, CA

Job Description

Job Description

  • Regulatory Affairs is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval.
  • Demonstrates working knowledge of healthcare-related regulations.
  • Demonstrates in-depth knowledge of preparing a submission.
  • Demonstrates in-depth knowledge of industry and competitive products.
  • Applies relevant regulations and statutes to further product submissions of basic to medium complexity.
  • Contributes to the strategic direction of regulatory pathway development.
  • Refines and conforms the preliminary data used in the submission process.
  • Translates technical data and descriptions into reviewer-friendly content.
  • Helps to ensure that the appropriate regulatory requirements for the submission are met.
  • Interacts with regulatory body to help further product approvals or clearance.
  • Works independently with minimal guidance.

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