Documentation Specialist Ii - Irvine, United States - QuinTalent Inc

QuinTalent Inc

Verified Company

Irvine, United States

1 week ago

Posted by:

Mark Lane

beBee recruiter

Description

Hybrid Monday-Friday 8am-5pm 3 days on site Tuesday,Thursday and one other day

1 year contract,
No fully remote and $40-45/hr all inclusive rate.

Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all our client's products currently CE Marked under the IVD Directive.

Activities include preparation revision of technical files when needed, update labeling to comply with IVDR requirements, track RA Regional notifications, and other related activities.

How You'll Make An Impact:

Support the IVDR labeling conversion and revisions of technical files for all products that are due to convert from the IVD Directive requirements to the new IVD Regulation.
Work crossfunctionally in weekly meetings to ensure the labeling conversion follows the plan.
Monitor the monthly manufacturing schedule, track change requests, monitor manufacturing timelines and update the labeling tracking log to ensure accuracy of the associated product lot numbers, RA Regional notifications, RA Regional followups and product restrictions, as required.
Update previous revisions of IVDR Technical Files to the latest template and include all the necessary attachments.

What You Bring:

Requires a Bachelor's degree in biochemistry, biology, medical technology or related fields
35 years of experience in RA, and/or QA, R&D, Manufacturing or Project Management in the IVD industry.
Experience on FDA, and CE marking requirements for IVD products is a plus
Able to work independently and with others
Communication skills, including negotiation and persuasion.
Analytical, problem solving, computer, and critical thinking skills.
Thorough knowledge of policies, practices and procedures related to RA.

Job Type:
Contract

Pay:
$ $45.00 per hour

Schedule: