Regulatory Affairs Manager

Regulatory Affairs Manager (Nicholasville, KY) F / T. Plan, direct, or coord production activities of our organization to ensure compliance w / regulations & standard operating procedures. Assist in implmtg Quality Mgmt System (QMS) as per ISO 13485 & 21 CFR 820 regulation. Author & submit applications 510 (k), PMA, IDE & tech'l documentation to regulatory agencies like FDA. $108,000.00 / yr. Master's deg in Regulatory Affairs for Drugs, Biologics & Medical devices or rltd, + 12 months of exp in job offered or as Regulatory Affairs & Quality Assurance Executive, RA Manager, or rltd position. Email resume to : Biopathogenix LLC, Attn : Preetpal Sidhu, Chief Executive Officer at : preetpal.sidhu@biopathogenix.com.

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