This individual is responsible for complaint investigations, regulatory reporting decisions and submissions for Philips Personal Health - Oral Healthcare business.
Your Role:
Is Responsible for the communication, coordination and collaboration with Product Safety Risk Managers, PMS Clinical Experts, Complaint Investigators, Product Engineers and business representatives as it relates to their areas of expertise and complaint investigations.
Is responsible for coordination and collaboration with Regulatory Affairs for preparing responses to regulators and competent authority inquiries when needed.
Performs data analysis to ensure business and quality requirements are met
Philips Personal Health provides opportunities to develop your career in a variety of ways; work on global team projects, work with business leaders and influencers to drive change, improve health outcomes and deliver meaningful experiences for the consumer. Our passion in Oral Healthcare will tap into your innovation with new experiences & desire to make a real impact on our customer’s personal health.
You're the right fit if:
Bachelor’s Degree in Biomedical Engineering, Biological Sciences, or other related technical degree.
1+ years of consumer product experience. 3+ years of direct experience in Complaint Handling and Vigilance Reporting in Medical Device or 5+ years of experience in another regulated industry.
Clear, concise and effective oral and written communication skills. Strong attention to detail and able to handle multiple priorities with tight deadlines.
Competency in initiating and running quality improvement projects. Moderate knowledge of Regulatory Requirements and Standards such as 21 CFR Parts 820, 803, 806; ISO 13485, ISO 4971, Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
Read more about our employee benefits.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
Philips Transparency Details
The pay range for this position is $89,376 to $153,216 annually. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
Additional Information
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Company relocation benefits will not be provided for this position. For this position, you will reside in or within commuting distance to Bothell, WA. USA
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.