Director Post Market Surveillance (Freelance)

In 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.

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).