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