Quality & Regulatory Manager

1. Quality System Management
• Ensures that the QMS is effectively established , implemented and maintained as required by regulations and standards.
• Drives an effective deployment of Philips Healthcare Quality System within GTC-NL.
• Drives the Quality Management Review Process
• Drives quality & regulatory compliance to assure products & services meet ISO and Quality Management System requirements
• Supports the deployment (and development when necessary) of training programs to meet the needs in areas such as quality & regulatory requirements, customer complaints and safety incident reports
• Executes audits where necessary as complement to the global and local audit program
• Ensures CAPA monitoring
• Supports and/or take the lead for GTC cross-site Quality initiatives

2. Post-Market Surveillance
• Management, monitoring & stimulation of the Philips customer feedback & complaint process including the receipt and subsequent closure of field related issue (per regulatory agency requirements when required).
• Drives Mandatory FCO regulatory communication timely execution.
• Approves measures to prevent unintended use
• Ensures escalations to BU’s and European Representative
• Monitors above mentioned processes effectiveness and takes the necessary corrective actions
• Review the communication towards BU’s when necessary
• Identify trended issues, which might have an impact on regulatory exposure

2. Regulatory Affairs Management
• Drives compliance with the applicable regulations and PH standards & policies.
• Supports BU’s in driving Medical Product Approvals process and submissions for the relevant components
• Supports regulatory inspections conducted by safety agency investigators and directs the formal response to any negative findings.
• Provides overview, analysis and interpretation of Regulatory issues and requirements as well as consequences on Quality Management System, business and budget.
• Supports the GTC Quality & Regulatory Manager in the development of detailed written responses to Competent Authority inquiries and warning letters to assure Philips continued ability to ship product.
• Assists BU’s and public relations efforts on regulatory issues, i.e. governmental efforts, Regulatory Warning letters and product recalls.

3. Management
• Manages Q&R (CAPA) engineers and supports the Customer Program team in performing Post-Market Surveillance
• Coach feedback team on the quality and handling of the feedbacks.
• Identify local feedback metrics and produce reports on trended product failures and feedback metrics. Is responsible for sustainability including environmental requirements
• Assists GTC Q&R Manager on creation and publication of QMS, feedback & recall data for Quality Management Review, analyzing data and proposing corrective actions when required.

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.

Ensures Philips Healthcare compliance to applicable medical device regulations from agencies such as the U.S. Food and Drug Administration, EU Competent Authorities, Japan MLHW, China SFDA and other international regulations for processing or administration of Quality Management Systems deployment, Auditing Customer Feedback & Complaints, Medical Vigilance Reporting, Corrective and Preventive actions (CAPA's) and supports Product Approval applications.
He/she is part of the GTC NL Management Team. And member of GTC global Q&R team.

Martijn Kempen

+31(0)6 21 135 787
martijn.kempen@philipssearchn.com