Regulatory Affairs Specialist – Protingent – Jobs in Union City, CA | OpenJobs AI

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Protingent

Job Details

Overview Company

Regulatory Affairs Specialist

$134k/y-$160k/y

Protingent

21 hours ago

Highlight

OnsiteFull-timeEntry

Summary

Protingent is seeking a Regulatory Affairs Specialist to join their team in Union City, CA. The role involves compiling, preparing, and reviewing regulatory documents necessary for submissions in accordance with regulations and relevant guidelines.

About the Role

As a Regulatory Affairs Specialist, you will be responsible for gathering and assembling information for regulatory submissions, maintaining regulatory databases, communicating with regulatory agencies, and ensuring compliance with FDA and global requirements. You will also interpret regulatory rules, maintain knowledge of emerging regulations, and assist in the coordination of product recalls or market withdrawals as necessary.

About You

Required:

Working knowledge of 21 CFR and FDA guidelines (GMPs) and international regulatory requirements.
Excellent computer skills in MS Word, Excel, and PowerPoint.
Strong attention to detail and ability to work on multiple tasks.

Preferred:

Experience in regulatory affairs within the medical device industry.
Demonstrated ability to coordinate and work effectively with cross-functional teams.

Benefits

Direct hire position with competitive salary.
Opportunity to work in a dynamic and innovative environment.

Protingent

Protingent is a technical staffing firm specializing in providing IT and engineering professionals for all areas of product design, development and test. We place high-caliber engineers with many of the leading technology companies in the U.S. We were founded in 2001 by an engineer and have always been dedicated to providing the right engineers who possess a high level of skill and knowledge regarding the technologies required to drive our clients’ success. The intrinsic value of any enterprise comes down to the quality of its people. Our clients understand that cutting-edge products aren’t designed and developed in a void. It takes exceptional people and consistent communication and collaboration. These beliefs are at the core of Protingent and have been instrumental in our ability to build a team of exceptional people.

Union City, CA