Regulatory Complaint Investigator
at Phillip Capital Inc.
Haifa, , Israel - 00000
|Start Date||Expiry Date||Salary||Posted On||Experience||Skills||Telecommute||Sponsor Visa|
|Immediate||18 Dec, 2019||Not Specified||19 Sep, 2019||1 year(s) or above||To succeed in this role, you should have the following skills and experience||No||No|
Required Visa Status:
|US Citizen||Student Visa|
|OPT||H4 Spouse of H1B|
|GC Green Card|
|Full Time||Part Time|
|Permanent||Independent - 1099|
|Contract – W2||C2H Independent|
|C2H W2||Contract – Corp 2 Corp|
|Contract to Hire – Corp 2 Corp|
In this role, you have the opportunity to act as “customer advocate”, and to manage and monitor complaints and adverse event reporting in full compliance with all applicable MD regulations, Philips Healthcare and Diagnostic Imaging policies and procedures.
You are responsible for overall execution of the CT/AMI Complaints & Reporting process, including:
- Process complaints in a uniform and timely manner
- Maintain, monitor, manage and/or update progress (status changes) and closures for each complaint record
- Screen incoming potential complaint reports to determine if the information meets the definition of a complaint.
- Review record for completeness of information and conduct necessary follow-up to obtain missing information.
- Determine if the complaint is a regulatory non-conformance
- Responsible for complaint Risk Assessments
- Completes initial assessment of reportability and notify the Adverse Event Coordinator(s) (AEC) when a complaint is reportable.
- Coordinate and/or conduct the Investigation of complaints and assign investigations to subordinate entities (Dual BU or component groups, suppliers - or Technical Investigation)
- Forward events that are potential accidental radiation occurrences to the Business Group Radiation Safety Officer.
- Forward malfunctions or defects that have resulted in accidental radiation to Correction and Removals via Product Safety Committee request.
- Ensure completeness and accuracy of complaint and/or non-complaint records.
- Communicate complaint conclusions to the Market Group when requested.
- Follow up with the end user/customer via Service when required
- Escalate via Corrective and Preventive Action (CAPA) Request, Product Safety Committee (PSC) Request, DEFECT Request, or Supplier Corrective Action (SCAR) Request when required.
- Initiate request for product ship holds when appropriate.
- Support audits (int. and ext.)
You are a part of
Quality and Regulatory Post Market Surveillance team.
To succeed in this role, you should have the following skills and experience
- Bachelor degree in bio medical, engineering, healthcare, nursing or related technical degree with 0 - 1 years of experience; OR:
- Bachelor degree with 1+ years of experience in a medical device or regulated industry.
- CT/AMI Products Knowledge is (Manufacturing Engineer/ Tech. support /Service Engineer) – an advantage.
- Basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001 – an advantage.
- Good communication skills and personal relationships.
- Very high level of verbal and written communication skills with English fluency. Native speaker – An advantage.
- Ability to work effectively in a team oriented environment.
In return, we offer you
To be part of a company that is committed to improving the lives of 3 billion people a year by 2025 through market-driven innovations in Healthcare, Lighting and Lifestyle. We are passionate about offering our employees the challenges, responsibilities, coaching and learning opportunities needed for their personal and professional development.
We believe in ample reward and special recognition for a job well done, and we welcome the cultural awareness, mutual understanding, open minds and out-of-the-box thinking that come from international multidisciplinary team working.
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 ChronicDisease_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 on our career website, where you can read stories from our employee blog at . Once there, you can also learn about our recruitment process at , or find answers to some of the frequently asked questions at .
bio medical, engineering, healthcare, nursing or related technical degree with 0 - 1 years of experience; OR: