Apply on Employer Site

Indotronix Avani Group · 1 day ago

Regulatory Affairs Specialist

Irvine, CA

Contract

Onsite

Mid Level

Indotronix Avani Group is seeking a Regulatory Affairs Specialist responsible for planning, coordinating, and implementing regulatory submissions for products requiring government approval. The role involves ensuring compliance with healthcare-related regulations and translating technical data into reviewer-friendly content.

ConsultingMachine LearningSoftware

Hiring Manager

Ravi Teja

Responsibilities

Regulatory Affairs is responsible for planning, coordinating and implementing regulatory Submissions 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

Has in-depth experience, knowledge and skills in own job family Applies knowledge and skills to a wide range of standard and non-standard situations Works independently with minimal guidance Usually determines own work priorities Acts as a resource for colleagues with less experience