Senior Manager - (US-CA-Foster City - 94404)

Minimum Education: None
Job Type: Full Time
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Responsibilities : Senior Manager, Quality Assurance and Regulatory AffairsThe candidate will report directly to VP, GM of EII. Strong dotted line report to HI/PM Senior Director, Quality and Regulatory. Provide management oversight and strategic direction for quality and regulatory activities within the business including: regulatory approvals, quality and environmental management system compliance, sustainability, product quality and process improvement. Provide leadership, vision, coaching, mentoring for the business' quality and regulatory organization Provide multi-site leadership to ensure the ongoing performance, safety and compliance of Philips' products and services. Drive regulatory strategy within the business to meet product development and release schedules. Work closely with the cross-functional management team to develop and improve business results through processes to speed time to market without sacrificing quality or compliance. Provide leadership to all business locations to ensure product quality and quality system compliance to ISO 13485 and FDA Quality System Regulation (21 CFR 820), Environmental compliance to ISO 14001, Canadian CMDCAS, Japan PAL regulation and all other worldwide medical device quality and environmental regulations. Coordinate quality and regulatory activities between business lines to create a common quality and regulatory direction for the business. Identify and implement best practices between all locations to improve efficiency without risking compliance. Champion product quality improvement. Provide regulatory information, opinion and interpretation to entire business.

Requirements :. A Bachelor's degree in a technical discipline is required. An advanced degree in law or management is strongly preferred. Should have 10 years of progressive management experience in a responsible quality assurance/regulatory affairs role in a software medical device environment. Expertise in FDA QSR, ISO13485 and European medical directives is required. Working knowledge of FDA regulations including 510(k) and MDR is required.

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