In this role, you have the opportunity to
Lead the EUMDR Program in Image Guided Therapy (IGT) cluster. This key leadership role provides the overall program leadership to successfully implement all aspects of EUMDR. This involves clear strategy, technical guidance and effective communication.
You are responsible for
Lead the strategy, set the direction and influence the solutions for EUMDR implementation in IGT.
Manage and deliver on all aspects of the EU MDR Program:
Develop Project Planning Tools for Review and Approval of timeline, content and responsibilities by the steering committee and sponsors.
Develop regular status reporting and communication tools for Steering Committee and Sponsors
Develop and deploy planning tools, RACI Charts and status reports with focus on deliverables for task forces
Provides business management with program performance status, variances to plan and identification of corrective actions.
Develop and manage EUMDR budgets working with cross-functional leaders to successfully implement EUMDR in IGT.
Establish and manage EU MDR cross-functional steering committees, trending and monitoring project timelines and deliverables.
Develop with the technical leads opportunities to work collaboratively externally with regulators, trade groups, customers, and other stakeholders regarding the development, review, and update of standards, guidance’s, whitepapers, and policies needed to resolve current issues and optimize current or emerging technologies
Works closely with various internal and external auditors including but not limited to Philips Level I, II and III and notified bodies to ensure timely implementation execution of EU MDR regulations
Manages impacted business work streams to align with Central Philips strategy and timing to execution
Work closely and collaboratively with various Q&R and cross-functional leaders to establish standardized reporting and tools to provide daily, weekly, monthly reports and updates to executive leadership team.
Needs to be able to work across functions and sites as well as work with the Philips End to End (E2E) Process Improvement Initiative’s Business Process Owners to ensure alignment of regulations and processes
You are a part of
The IGT business within Philips. This is a critical role in the cluster Q&R leadership team and provides an excellent opportunity to interact with key functions and leaders with broader Philips. This is a single contributor role and no direct reports. However, you will work closely with program managers in Best and US and you have a lot of interaction with the business. The supporting teams are customer driven, open to new ways of working and have a strong quality culture.
To succeed in this role, you should have the following skills and experience
Degree in Engineering or Science, a Master’s degree would be a distinct advantage
10+ years’ experience in the quality function in a Medical Device industry
Strong program management skills with a consistent record of accomplishment of leading key compliance programs through direct and/or indirect line management.
Experienced knowledge of EUMDR and appropriate global medical device regulations, requirements, and standards, such as FDA, ISO13485, ISO14971 and European Medical Device Directive (93/42/EEC).
Fair understanding of global regulatory landscape is required with keen understanding of patient safety and product quality dedications
Familiar with business process management frameworks include the best industry practices as it pertains to QMS
Experience in change management is required.
Relevant training, experience and certification in Continuous Improvement practices such as Lean/ Six Sigma preferred
Business Insight and strong Business Partnering Skills is a distinct advantage
Highly collaborative influencer who is an effective communicator and relation builder/ networker
Proven ability to lead cross-functional, diverse teams with competing goals
Willing to travel up to 25%
In return, we offer you
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:
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 create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .