PDAC Medical Device Specialist (233785) Remote

Engineering Services | Healthcare IT | Life Sciences & Technology

Start date: ASAP

Location: Remote-based

Duration: Open-ended / Ad-hoc

Hours per week: As needed

Job description:

Our Medical Device client is currently looking for someone to assist with E0218 compliance as is related to PDAC for a water circulating cold pad with a pump in which classifies as a 510k Class II Medical Device. The current QMS is in place and the PDAC code will need to be applied along with timelines that need to be implemented to meet the EOY 2023 deadline. The 60601 testing UL has progressed and they now need someone to establish PDAC codes, specifically the E0218. Experience with products similar to the DonJoy Iceman Cold Therapy or Polar Cube Water Circulating Pads will be relative/helpful.

Experience with class II medical devices, PDAC codes / E0218 application, and a proven track record of the above scope will be required.

PDAC Medical Device Specialist (233785) Remote



About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
Remote, United States

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