In this role, you have the opportunity to
As a Clinical Complaint Investigator, you will support MDR/adverse event reporting, triage complaint records, manage high-risk complaints and act as a clinical/training resource for other team members. You are responsible for
Worldwide management of post-market risk processes to ensure compliance to the regulations.
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.
Draft customer letters for sensitive Death/Serious Injury (D/Si) cases as needed.
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
The Emergency Care and Resuscitation Solutions (ECR) Post Market Surveillance Team is headquartered out of Andover, MA. We welcome you to join Philips HealthTech as a Complaints Specialist supporting ECR. The Quality and Regulatory team enables meaningful innovation for our customers by partnering with and guiding the business to achieve world-class quality and regulatory compliance in a rapidly changing environment, while creating a great workplace for our people to realize their career aspirations. To succeed in this role, you should have the following skills and experience
Bachelor’s degree required. Nursing degree (BScN or higher) or other relevant medical degree combined with five years clinical experience, preferred.
3 years’ experience working in a post market role preferred.
Experience with Complaint Handling Software, Databases, and Microsoft Office.
Excellent communication skills (verbal, written, and presentation)
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. In return, we offer you At Philips, we strive to make the world healthier and more sustainable through innovation, and our goal is to improve the lives of 3 billion people a year by 2025. This position offers the opportunity to influence regulatory compliance worldwide and directly improve the customer and patient experience. We offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. 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 . 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 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 .