Regulatory Affairs Consultant II

Description:
 
Support Business Regulatory Affairs team by preparing regulatory submission packages for a manufacturing site change. This may include: 
 • Review and approve quality documentation 
 • Review and approve product/solution labeling and product/solution-related marketing communications 
 • Review documentation to ensure that the information required for submissions is adequate 
 • Plan, generate, and coordinate regulatory submissions for product/solution licensing 
 • Coordinate testing required to support regulatory submissions 
 • Maintain existing regulatory filings/ licenses, managing updates and related change control processes 
 
 Requirements/Experience 
 • Bachelor’s degree in a technical discipline 
 • RAPS certified (Regulatory Affairs Professional Society) 
 • Minimum of 3-5 years of experience in the medical device industry and technical environment with at least 3 years working for electromechanical medical device company 
 • Must have experience with successful preparation and submission of 510(k), PMA, or international documents for registration and marketing of medical devices worldwide 
 • Excellent knowledge of medical device regulations (21CFR), FDA law, MDD/MDR, other global laws and regulations 
 • Experience in international registrations 

Thanks and Regards,
 
Milind Kerkar
APN Software Services, Inc
39899 Balentine Drive, Suite 385, Newark, CA 94560
Direct Phone: 510-402-1080     
 milind@apninc.com

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