In this role, you have the opportunity to
Work with a variety of diverse persons within the company such as Engineers, Scientists, Field Service & Application Engineers and Manufacturing personnel to facilitate reportable device events in accordance with written procedures and global reporting requirements.
You are responsible for
Works together with Complaint Investigators during initial check/ reportability determination.
Reviews complaints to ensure that all information needed for Reporting/MDRs is present; determines if further investigation is needed and tracks investigation to conclusion
Follows up reporting decisions together with complaint investigators till investigation is completed.
Writes MDRs/MIR reports ensuring that the information is accurate and complete as per applicable requirements.
Works together with Complaint Investigators to address Competent Authority inquiries and prepares the responses for such inquiries.
To succeed in this role, you should have the following skills and experience
Working knowledge of appropriate global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169.
Good Verbal and written communication skills.
Analytical skills and focus on detail.
Teamwork in and outside Q&R.
Fluent in English (verbal and written).
Product Knowledge is preferred.
Medical Device and or other regulated industry (e.g. Pharma, IVD) is preferred
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 .