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MillenniumSoft Inc · 3 days ago

Senior Regulatory Affairs Specialist - Onsite (Urgent Need)

Irvine, CA

Contract

Onsite

Senior Level

MillenniumSoft Inc is seeking a Senior Regulatory Affairs Specialist to manage regulatory submissions for a medical devices company. The role involves coordinating and implementing submissions, ensuring compliance with healthcare regulations, and contributing to the strategic direction of regulatory pathways.

Staffing & Recruiting

No H1B

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

Qualification

Regulatory AffairsHealthcare regulationsSubmission preparationTechnical data translationStrategic regulatory pathwayResource for colleaguesIndependent work