In this role, you have the opportunity to
•Manage worldwide post-market risk processes for assigned product category to ensure compliance to the regulations.
You are responsible for
Access clinical risk of reported complaints using risk management tools, medical literature, or consultation with medical professionals. Make clinical severity assessments, classify and advise on FDA defect codes.
Lead investigations and follow up activities for all adverse events reported. Perform complaint and quality investigations related to manufacturing, design or clinical use issues.
Investigate and prepare responses to address Competent Authority inquiries and provide follow-up.
Assist with post-market health hazard evaluations as needed.
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.
Provide clinical and 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
•Professional complaint handling Team, with around 10 team peers globally.
To succeed in this role, you should have the following skills and experience
•Education: Bachelor degree, major in engineering discipline or equivalent is preferred.
•Experience: At least 3 years of Quality and/or Regulatory experience in medical or highly regulated industries, experience in Post-market Surveillance/compliant handling is an advantage.
•Competencies and skills:
•Good command of English and Chinese Language skill is required.
•Demonstrated strong results orientation.
•Proficiency using statistical tools, office tools, and various other computer software applications.
•Must be able to work under pressure to meet regulatory reporting timeframe and company requirements.
•Be willing to work outside of normal working hours as needed to accommodate businesses in multiple time zones.
•Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment
•Requires the proven ability to consistently meet and/or exceed goals.
•Must be capable of making commitments, setting priorities, and delivering results on time.
•Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives
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 .