I n this position, you have the opportunity to
Provide leadership and deliver the compliance and business objectives of the function, with primary responsibility in developing & leading compliance to Post Market Surveillance (PMS) requirements throughout the international Markets. You act as the leading PMS Subject Matter Expert (SME) and Proof of Concept (POC) for International Markets. This Director role will have responsibility to maintain full compliance to the Quality System Regulations including Philips Global Philips Quality Management Systems (PQMS) Procedures. You can work from our office in Amsterdam or Eindhoven or home-based within Europe.
You are responsible for
The strategy, co-ordination and measurement of PMS-related activities for the International Market and will ensure an effective utilization of data to drive dedicated improvements whist maintaining an audit ready state. A strength in PRIDE and Daily Management is important for this role.
Being the PMS SME within the Philips HealthTech and Personal Health Markets Function. Supporting International Q&R leaders and Philips Legal Manufacturers to meet Post market surveillance requirements for the full Philips Portfolio (Medical devices and consumer products).
Contributing to the development and implementation of Quality Planning associated with our Market and customers, specifically as pertains to PMS data and potential risks identified via Audit and Regulatory body findings.
The development and mentoring of PMS competency throughout the international markets, establishing best -in -class PMS execution. You will influence & drive improvement pro-actively with Market leaders/Market Q&R leaders through forums such as Center of Excellence (COE), Management review and Quality Planning.
Supporting leaders operating within a Multi‐Country Region (16 countries), ensuring timely/complaint execution of Philips PMS processes and driving process improvements.
Supporting the markets in order to meet PMS requirements in their deployment of Field Change Order (FCO) and compliance of FCO, Field Safety Notice (FSN).
Leading and supporting resolution to Q&R related questions, guidance, co-ordination and alignment as it related to PMS tools and processes.
Driving compliance and lean improvements to the PMS processes. Leading and processing related systemic CAPAs.
Driving the standardization and best in class execution by International markets teams in their processing and administration of customer feedback & complaints, safety reporting, medical vigilance reporting, coordination of Field Corrective Actions and interactions with local government & agencies.
You are a part of
Q&R International Markets team consisting of PQMS Team (operating the Multimarket Philips QMS), and International Market Q&R leaders. You will have 1 report and will matrix lead other people to execute PMS processes
Key partner to Global PMS PQMS team and Philips Excellence Process Framework Business Process Owners/Business Process Experts.
To succeed in this role, you should have the following skills and experience
Bachelor/Master Degree (Life Science, Pharmaceutical, Medical Engineering, or similar technical discipline) and have at least 10 years’ relevant experience in Medical Devices or Pharma.
In depth knowledge of key requirements for Post Market Surveillance, Complaints Handling and Field Safety Action.
Experience in quality management systems is essential, with strong knowledge of ISO 13485, 9001, and 14971 (Risk management)
Strong leadership experience: leading a team within an international matrix organization, influencing without authority and working closely with executive leadership
Experience collaborating with regulatory bodies/health ministries in applicable markets and respective countries. Previous experience with US FDA inspections is a plus.
Must possess strong communication, project management and leadership skills as well as have the ability to manage multiple projects simultaneously
Capable of working as part of a multi-disciplined team.
Demonstrated ability to successfully manage and complete and complex projects in a matrix organization
Training in Lean and Lean Methodologies is a plus.
Open to travel up to 25% (about 1 week a month).
In return, we offer you
We welcome you to a challenging, creative environment with great opportunities for you to explore.
Our benefits are very daring and designed around your preferences:
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
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to build a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.