Onsite Engineering PM: Regulated Diagnostics Submissions

MillenniumSoft Inc; San Diego (CA); Presencial; USD 110.000 - 150.000; Jornada completa

Descripción de la vacante

MillenniumSoft Inc. in San Diego, CA, seeks an Engineering Project Manager with regulated industry experience.

This onsite role focuses on technical dossier audits, regulatory readiness for clinical diagnostic products, and cross-functional collaboration with RA, R&D, Quality, and Marketing to ensure submissions meet global requirements. Responsibilities include developing integrated project plans, coordinating document reviews, facilitating gap assessments, and driving remediation plans to

Formación

• Bachelor's degree in a scientific, engineering, regulatory, or related discipline.

Responsabilidades

• Lead cross-functional technical dossier audit projects supporting regulatory re-registration and product sustainment initiatives.

Conocimientos

Strong PM skills

Cross-functional leadership

Risk management

Excellent communication

Project coordination

Meeting facilitation

Analytical/problem solving

Matrix organization experience

Educación

Bachelor's degree in a science/engineering/regulatory field

PMI PMP certification (preferred)

Herramientas

Microsoft Project

Microsoft Excel

PowerPoint

Descripción del empleo

MillenniumSoft Inc. in San Diego, CA, seeks an Engineering Project Manager with regulated industry experience.

This onsite role focuses on technical dossier audits, regulatory readiness for clinical diagnostic products, and cross-functional collaboration with RA, R&D, Quality, and Marketing to ensure submissions meet global requirements. Responsibilities include developing integrated project plans, coordinating document reviews, facilitating gap assessments, and driving remediation plans to