Job Listing Description

Regulatory Affairs Specialist II

Chipton-Ross is seeking a Regulatory Affairs Specialist II for a remote opening.

Prepare, compile and publish electronic pre-market and post-market regulatory submissions
Compile Technical Files and Design Dossiers for IVD medical devices to support EU CE-Mark Interact with business partners to support WW submissions for IVD medical devices (Asia PAC, Mexico, Brazil, Canada etc.).
Develop and execute submission strategies for assigned projects.
Monitor progress on key project deliverables and provide status updates on regular basis.
Review of product labeling, literature and Web site for accuracy, consistency and regulatory compliance Develop and/or revise regulatory procedures

Demonstrated ability to coordinate complex projects.
Strong oral and written communication and presentation skills
Solid working knowledge of the US Regulations and European IVD and medical device directives
Good analytical and problem-solving skills.
Demonstrate in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
Experience with International submissions and IVDs highly desirable Capacity to communicate regulations to technical functions within the company
Ability to manage relationships with international customers (e.g., regulatory agencies, distributors, etc.)
Solid computer skills in Microsoft Office
International RA experience preferred or a minimum of 1-year direct experience in Regulatory Affairs within the IVD Industry

Understanding of FDA and European Medical device and IVD regulations.
Working knowledge of the medical device product lifecycle.
Product design and manufacturing change assessments for regulatory reporting.
International regulations and submissions

Accredited Bachelor’s degree required in the life sciences or engineering with a minimum of 2 – 4 years direct experience in Regulatory Affairs (within an IVD industry preferred).

1st Shift

Job Number: 186574
Job Location: Remote,
Rate: $DOE
Duration: 5 Months
Input Date: 07/30/2020
Attention: Tyler Harrell
Address: 420 CULVER BLVD
City, State: PLAYA DEL REY, CA 90293
Phone: 310/414-7800 X286
800 Phone: 800/927-9318
Fax Phone: 310/414-7808

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