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Career Professionals, Inc. has been serving the professional and technical staffing needs of southeastern manufacturers since 1985

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Regulatory Affairs Specialist (FDA)

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Location
Eastern TN, TN
Salary
$50,000 - $60,000
Job Type
Direct Hire
Degree
Bachelor of Science
Date
Jun 07, 2018
Job ID
2602914
Medical device manufacturer in E.TN has immediate need for a Regulatory Affairs Specialist. Will prepare global regulatory submissions and work closely with product development teams to ensure compliance. The Regulatory Affairs Specialist is responsible for developing and reviewing submissions, documentation, labeling, and procedures for compliance with 21 CFR 820, EU 2017/745 and other regulatory standards.

The Regulatory Affairs Specialist will maintain licensure for Pharmaceutical packaging, approve labeling for FDA and international requirements, and maintain medical device registrations. Will also handle FDA customs import / export requests.

Qualified candidates will have 3-5 years experience in an FDA-regulated industry, with medical device or pharmaceutical experience preferred. Must have BS degree along with extensive knowledge of FDA regulations.

Excellent company with a strong presence in E.TN supplying a global customer base.