Philips Director, Quality & Regulatory in Amsterdam, Netherlands
The Director of Q&R for Connected Digital Platforms and Propositions (CDP2) is required to be a hands on, highly participative manager, responsible for leadership and direction of Quality Assurance and Regulatory Affairs organization. The Director is responsible for the promotion of quality awareness and continuous improvement throughout the organization while developing, implementing, maintaining and improving the quality system and ensuring compliance with all applicable regulatory requirements and all applicable Philips Healthcare and Connected Digital Platforms and Propositions (CDP2). You are responsible for ensuring that the overall business unit processes and initiatives are compliant with all applicable Software and Hardware external standards and regulatory requirements. You will work on body worn monitors in order to improve people’s lives. You can work either from Amsterdam or Eindhoven.
Identify and implement best practices to improve efficiency and maintain compliance and lead the function in continuous process improvement.
You daily manage a team of 7 employees (RA and Quality related) based in the Netherlands and Bangalore.
Ensures that regulatory strategies adequately support product development activities and result in the timely approval of new and revised products; thus, must have good knowledge of US regulation and general knowledge of European Regulations, including the Medical Device Directive and Health Canada 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.
Works with Corporate Quality Assurance and other quality assurance and regulatory leaders across the corporation to identify and implement best practices.
Maintains productive working relationships with external regulatory bodies.
Implements appropriate activities to ensure regulatory compliance and adherence effectiveness of the quality system such as: complaint handling, corrective and preventive action, and the internal audit program.
Monitors external changes to the regulatory environment to ensure the continued compliance of the quality system.
Philips CDP2 is an entrepreneurial business in Philips Population Health Management. CDP2 combines leading technology and data-driven population management with clinical expertise and a proven programmatic approach.
You will be responsible for a team of approximately 10 Quality professional spread across:
Software Design Quality Engineers, working directly with Platform and proposition software development teams.
Quality Management Systems, Constantly monitoring and updating the QMS.
Quality support staff for QMS systems, such as CAPA, Complaint management and Supply chain monitoring.
Philips is one of the world's leading healthcare technology companies. We are committed to understanding the technological and human needs of patients and caregivers and to delivering solutions that enable more confident diagnoses, more efficient delivery of care, and more positive user experiences. People focused. Healthcare simplified.
We welcome you to a challenging, innovative environment with great opportunities for you to explore. Our benefits are very competitive and designed around your preferences:
We offer a market conform salary
25 Days of leave and the possibility to purchase up to 20 extra days off annually
A variable bonus based on both Philips results and personal performance
Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
Solid company pension scheme and attractive collective health insurance package
Opportunity to buy Philips shares and products with discount
Healthy work-life balance
We are looking for
To be successful in this role, you need to have:
Bachelor's degree (Software, Science, Engineering or similar technical discipline) required, Master's degree in business, management or quality strongly preferred
Minimum of 8 to 10 years of work experience, including a couple of years progressive management experience in a responsible Quality Assurance/Regulatory Affairs role (required)
Experience in Quality Systems and in Regulatory Compliance (required)
Medical Device experience (required)
Experience in validation of software systems and systems security and control (preference)
Experience with computerized systems implementations, comprised of multiple application types, in a regulated environment
Demonstrated ability to interact and communicate (both oral and written) with project team/ organizational members, business leaders and senior executives.
Experience with FDA and other world-wide standards and regulations is preferred
Good people management skills
Please share your resume and best moment in Recruitment with us. After a pre-selection process on your resume you will receive an invite for an introduction meeting by phone. If positive, you will be invited for (face-to-face) interviews.
If you have any remaining questions regarding this vacancy, please do not hesitate to contact Annette van Kamp-Rustenburg on tel +31-625714986