Vigilance Reporting Specialist
In this role, you have the opportunity to
- As a Vigilance Reporting specialist, you will lead Removal/recall/MDR report/adverse event reporting, triage complaint records, manage high-risk complaints and act as a training resource for other team members.
You are responsible for
- Worldwide management of post-market risk processes to ensure compliance to the reporting regulations.
- Evaluate removal/recall/MDR report/adverse event/complaint and make reporting decision based on China and EU reporting regulation.
- Responsible for Removal/recall/MDR report/Adverse event reporting to China NMPA and EU REP;
- Lead investigations and follow up activities for all removal/recall/MDR report/adverse events report.
- Investigate and prepare responses to address Competent Authority inquiries and provide follow-up.
- Periodic monitor removal/recall/MDR report/adverse event status until closed.
- Analyze complaints and adverse events and communicate issues and resolutions to management.
- Review and approve all decision trees related to deaths and adverse events.
- Review product complaints associated adverse events to ensure they are in compliance to all applicable regulations, requirements, corporate, site, and international policies and procedures.
- Provides review of complaint to ensure all information needed for Reporting/MDRs is present; determine if further investigation is needed and track investigation to conclusion,
- Assist with post-market health hazard evaluations as needed.
- Provide compliance training to support post market surveillance team.
- Foster an environment of continuous improvement that drives quality employee engagement through coaching, critical quality thinking, mentoring, and appropriate escalation.
- Influence effective compliance based decisions with cross-functional communication and team building skills.
You are a part of
- Bachelor’s degree required. Nursing degree (BScN or higher) or other relevant medical degree is preferred.
- At least 3 years reporting experience in medical device industry or Hospital is required.
- Familiar with medical device report regulation, especially in EU and China.
- Experience working in a complaints handling or post market role preferred, experience with Complaint Handling Software, Databases, and Microsoft Office is preferred
- Excellent Chinese and English communication skills (verbal, written, and presentation) are required
- Ability to interpret Regulations, Corporate, Division and Department procedures.
- Ability to translate quality and safety requirements into product specifications.
- Working knowledge of quality systems and relationship to business.
- Ability to effectively manage time.
- Ability to handle multiple task assignments.
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 2.5 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.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there,you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
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Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven.
Little did they realize that it would become a global force of innovation, committed to
improving billions of lives worldwide. But it did.
Today, Philips is a world leading health technology company with a vision to make life better
for people worldwide through meaningful innovation. Making good on this promise depends on our
passionate, inspirational, collaborative and diverse team.
We have over 80,000+ brilliant people around the world but are always looking for more.
Like-minded, motivated, focused minds to join us in creating a healthier, more connected society
while tranforming themselves personally and professionally.
Working at Philips is more than a job. It's an experience filled with unexcepted moments that
will transform you in lasting and positive ways. Help us improve the world for the better while
building a career that no one could have planned for. Even you.