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Vice President Quality & Regulatory Affairs

at Philips Electronics North America Corporation in Andover

We simplify healthcare by focusing on the people in the care cycle patients and care providers. Through combining human insights and clinical expertise, we aim to improve patient outcomes while lowering the burden on the healthcare system. Philips delivers advanced solutions for both health professionals, to meet the needs of patients, and empowered consumers for affordable healthcare whether in hospital or at home.

Some product highlights: 256-slice Brilliance iCT scanner, Integrated cath lab, Avalon FM 20 & FM 30 fetal monitors, Ambient Experience MR and CT systems, Philips Lifeline's personal emergency alert service.

Reporting directly to the Executive Vice President of Global Sales & Services International and functionally to Philips Healthcare as Chief Legal Officer, as well as to the GM & Senior VP of Global Customer Services and the Executive VP of the North America Sales and Service Organization. This position provides strategic leadership in the area of Quality & Regulatory Affairs for Philips' Global Customer Service (GCS) and worldwide Global Sales and Service (GSS) Organizations.

Your Responsibilities:
Develop and successfully implement global strategic objectives for quality system and regulatory harmonization for all Philips Healthcare to increase revenue through improved business process efficiency and speed to market

Provide strategic leadership, vision, coaching, training, mentoring for the GCS/GSS Quality & Regulatory organization to ensure Quality System compliance to worldwide quality system regulations and applicable standards

Responsible for creation, compliance and deployment of Sector-wide Quality System policies and procedures as well as harmonized GCS/GSS- specific Quality System procedures and training systems and policies

Responsible for ensuring customer feedback, including complaints, are properly communicated to Business complaint handling teams and ensuring proper communication to regulatory bodies and customers as required

Responsible for deploying, tracking and reporting recalls and all types of FCO status to Businesses, customers and regulatory bodies as required

Represent Philips Healthcare in Q&R matters of field-related product and process issues involving Philips products and services to internal or external stakeholders

Represent GSS/GCS Q&R on the Philips Healthcare Q&R Executive Team

Report legal status and health of the GCS/GSS global businesses to CEO and Executive VP as and cross-functional senior leadership team through management and business reviews

Create global GSS/GCS Q&R policies to improve business results by aligning with strategic initiatives across Philips Healthcare

Provide counsel and resources for defining and implementing Sector-wide Quality and Regulatory strategies and objectives including one page strategies and KPI as

Participate actively in steering and influencing national and international government, trade and standards organizations aimed at setting worldwide regulatory and quality policies affecting Philips Healthcare as medical devices

Your Profile:
Greater than 15 years working in Quality and Regulatory Affairs in the medical device industry. Strong leadership skills. Extensive experience working directly with FDA and other worldwide regulatory agencies. BS/BA required, advanced degree in business or law preferred.

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