Job Description
Reporting directly to the General Manager, this position leads all aspects of the Emergency Care Solutions' operations and products global Quality, Compliance and Regulatory Affairs programs to ensure the ongoing availability, safety, and compliance of all products. Candidate Responsibilities: * Lead the Quality and Regulatory function for the emergency care solutions business, and ensure the leadership team is fully aware of roles, responsibilities and required actions. * Provide strategic direction and operational management for quality and regulatory activities including: regulatory approvals, world-wide Quality System regulations compliance, quality management system implementation. * Provide leadership to the quality & regulatory organization, ensuring clear and aligned objectives, support employee development with feedback and coaching, drive employee engagement, and encourage collaboration with all stakeholders. * Provide regulatory expertise and guidance, including expert interpretation and insight to all business functions ensuring regulatory strategy supports product development goals and release schedules. * Provide the same support for all existing products. * Provide leadership to ensure product quality and quality system compliance to ISO 13485 and FDA Quality System Regulation (21 CFR 820), Canadian CMDCAS, Japan PAL regulation and all other worldwide medical device quality regulations. * Represent the business during any audit processes, internal or external. Drive compliance across all functions of the business and ensure preparedness for any audits. Take action on any audit findings, to reinforce compliance or remedial action on any unsatisfactory findings. * Identify and implement best practices to improve efficiency and maintain compliance and lead the function in continuous process improvement. * Ensure strategic alignment of quality and regulatory activities with business objectives to ensure continued compliance and zero negative audit reports. * Represent Q&R activities at the management level including Management Review and participate on the Philips Healthcare Quality Council.
Desired Skills & Experience
Your Profile
* Bachelor's degree (Science, Engineering or similar technical discipline) required * Master's degree in management or quality strongly preferred * Minimum 10 years of progressive management experience in a responsible quality assurance/regulatory affairs role in a medical device environment. * Experience with FDA Class III and/or therapeutic devices strongly preferred. * Proven experience managing quality, regulatory and risk management activities * Experience in quality systems associated with the development, manufacture and support of hardware and software medical products and applications. * Proven expertise in World-wide standards and regulations including ISO13485 and European medical directives, ISO 14971, Japanese PAL requirements and Canadian CMDCAS. * Proven expertise in FDA regulations including QSR, pre-market and post-market regulations. * Experience in direct interactions with world-wide regulatory authorities * Proven leadership in formulating and implementing global strategies to ensure product quality, compliance with worldwide regulations and timely product approvals to meet business objectives * Strong communication skills and a highly collaborative style * Achievement oriented and customer focused
Contacts
Notes
Philips is an equal opportunity employer
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Email: jobs@aarenconsultants.in
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