Director of QA & Regulatory Affairs

ChromoLogicMonrovia, CA

Apply with Sonara

Automate your job search with Sonara.

Submit 10x as many applications with less effort than one manual application.¹

Reclaim your time by letting our AI handle the grunt work of job searching.

We continuously scan millions of openings to find your top matches.

Overview

Schedule

Full-time

Education

Engineering (PE)

Career level

Director

Job Description

About Us

We are seeking an experienced and highly qualified Director of Quality Assurance and Regulatory Affairs to lead quality systems and ensure compliance with all applicable regulatory requirements. This role will oversee quality assurance processes, regulatory submissions, and audits to maintain product integrity and adherence to industry standards.

ChromoLogic LLC (www.chromologic.com) is a world-class innovation center with advanced scientific research and development in the medical, aerospace and security markets. Covisus Inc. (www.covisus.com) is a VC-funded spin-off from ChromoLogic that has developed an award-winning and industry-leading technology for tagless tracking of assets based on its vTag® technology.

Key Responsibilities

Develop and implement quality assurance strategies and regulatory compliance programs (FDA 510(k), PMA, IDE, drug approval, IND, pre-submission)
Ensure adherence to FDA, ISO, and other relevant standards (IRBs, HRP, clinical study protocols, animal study protocols (IACUC, OLAW, ACURO))
Oversee internal and external audits, inspections, and certifications
Manage regulatory submissions and maintain documentation for compliance
Collaborate with cross-functional teams to ensure quality throughout the product lifecycle
Lead and mentor QA, regulatory, and safety teams to achieve organizational goals
Monitor changes in regulations and update company policies accordingly
Ability to obtain security clearance

Qualifications

Bachelor's or Master's degree in engineering, life sciences, or related field
10+ years of experience in QA and regulatory roles
5+ years in leadership roles, with a proven track record of managing people and processes
Excellent communication, leadership, and strategic skills

What We Offer:

Competitive salary and benefits package, including stock options
Opportunities for professional growth and development
A collaborative and inclusive work culture
The chance to work on cutting-edge technology projects that make a real-world impact

Automate your job search with Sonara.

Submit 10x as many applications with less effort than one manual application.

Apply with Sonara Apply manually

FAQs About Director of QA & Regulatory Affairs Jobs at ChromoLogic

What is the work location for this position at ChromoLogic?

This job at ChromoLogic is located in Monrovia, CA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at ChromoLogic?

Employer has not shared pay details for this role.

What employment applies to this position at ChromoLogic?

ChromoLogic lists this role as a Full-time position.

What experience level is required for this role at ChromoLogic?

ChromoLogic is looking for a candidate with "Director" experience level.

What education level is required for this job?

The education requirement for this position is Engineering (PE). Candidates with relevant qualifications or equivalent experience may also be considered.

What is the process to apply for this position at ChromoLogic?

You can apply for this role at ChromoLogic either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.