In this role, you have the opportunity to
Lead and manage Q&R activities in the Iberia Market. This includes direct responsibilities for Post-Market Surveillance (PMS) and dotted line responsibilities for Q&R activities.
You are responsible to
Post Market Surveillance: Responsible for processing and administration of Customer Feedback & Complaints, Safety reporting, Medical Vigilance Reporting, coordination of FSN/FCO and interactions with local Gov. Agencies.
Regulatory Affairs: Ensuring Philips Markets Organization compliance to applicable Philips policies and applicable processes, and Regional regulations. This includes submissions for country approvals, certificates and registrations.
QMS: Quality Management Systems deployment, Auditing, managing Corrective & Preventive actions (CAPA) and for the promotion of quality awareness.
Deployment and Compliance to Q&R requirements for countries under the umbrella of the Market.
To succeed in this role, you should have
Bachelor Degree (Life Science, Pharmaceutical, Medical Engineering, or similar technical discipline). Advanced degree preferred in technical or clinical field
Minimum of 6 years’ experience; at least 4 in the medical device/ pharmaceutical industry, regulated environment
Experience with managing product approval process in applicable markets and respective countries
In depth knowledge of key requirements for Post Market Surveillance and experience interfacing with regulatory bodies/health ministries
Must have strong knowledge of ISO 13485, 9001, and 14971 (Risk management).
In return, we offer you
to be at the heart of Philips and share our passion for introducing meaningful innovation in our daily life; advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first.
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