Engineering Management & Business Others Marketing and PR Medical and Healthcare
3 - 5 Years
June 29, 2020
Vigilance Reporting Manager
Vigilance Reporting Manager
In this role, you have the opportunity to
Be part of a fast-growing business that help improve the lives of millions of people, while advancing Philips digital transformation journey as a global leader in Health Technology.
You are responsible for
Organizing the team to achieve on-time, correct and consistent Vigilance reporting.
Supporting organizational changes and improvements. Driving improvements in team processes and way of working.
Working 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.
Working together with Complaint Investigators during initial check/ re-portability determination.
Reviewing complaints to ensure that all information needed for Reporting/MDRs is present; determines if further investigation is needed and tracks investigation to conclusion.
Following up reporting decisions together with complaint investigators till investigation is completed.
Writing MDRs/MIR reports ensuring that the information is accurate and complete as per applicable requirements.
Addressing Competent Authority inquiries and prepares the responses for such inquiries.
You are a part of
A young, dynamic and multicultural team, a small group of experts constantly striving for improvements, within an ever-changing environment, and exceeding internal and external stakeholder expectations.
To succeed in this role, you should have the following skills and experience
4+ years experience in a medical device or other regulated industry is an advantage.
Strong experience with Post Market Surveillance, complaint handling and Adverse event reporting for medical devices.
Capability to organize and lead a team.
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 (EU MDR), Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169.
Advanced Excel and analytical skills and focus on detail.
Experience with writing technical and regulatory documentation and fluency in English.
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise.
Why should you join Philips?
Working at Philips is more than a job. Its 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. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
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