In this role, you have the opportunity to
Lead the Q&R function within the Philips HealthTech Markets Function supporting Pre and Post markets action for the full Philips Portfolio (Medical devices and consumer products). Your role is to manage the Quality & Regulatory function for the Multi‐Country Region (16 countries), ensuring compliance and process improvements. You will be supporting business for new product introductions, regulatory clearances, Field corrective Actions and Customer Service operations..
You are responsible for
Leading and managing Q&R activities in the MET market. This includes direct responsibilities for Post-Market Surveillance (PMS) and dotted line responsibilities for Regulatory Affairs and Quality Management System.
Processing and administration of customer feedback & complaints, safety reporting, medical vigilance reporting, coordination of Field Corrective Actions and interactions with local government & agencies
Ensuring Philips markets organization compliance to applicable Philips policies and applicable processes, and regional regulations. This includes submissions for country approvals, certificates and registrations.
Quality Management Systems (QMS) deployment, Auditing, managing Corrective & Preventive actions (CAPA) and for the promotion of quality awareness in the region.
Deployment and compliance to Q&R requirements for countries under the umbrella of the MET market.
You are a part of
Quality & Regulatory function for the Multi‐Country Region (16 countries)
To succeed in this role, you should have the following skills and experience
Bachelors Degree (Life Science, Pharmaceutical, Medical Engineering, or similar technical discipline)
Must have strong knowledge of ISO 13485, 9001, and 14971 (Risk management)
Preferred experience in medical device/pharmaceutical industry, and regulated environment
Experience with managing product approval process in applicable markets and respective countries
In depth knowledge of key requirements for Post Market Surveillance, Complaints Handling, and CAPA and experience interfacing with regulatory bodies/health ministries
Previous experience with US FDA inspections is a plus.
Experience leading a team within an international matrix organization.
Strong leadership and business partnering, working closely with executive leadership.
In return, we offer you
Supporting business for new product introductions, regulatory clearances, Field corrective Actions and Customer Service operations
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.
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 .