Frequently interacts with complaint investigators, Philips management, regulatory agencies, Philips market representatives, and customers, and/or functional peer group managers regarding incident reporting matters
Writes MDRs/MIR reports and submit to the necessary authorities
Work with complaint investigators to prepare responses to address Competent Authority inquiries
To succeed in this role, you should have the following skills and experience:
Timeliness of incident reports (MDR, MIR, others)
No-major non-compliance in applicable process/records.
Good Verbal and written communication skills
Analytical skill and focus on detail
Teamwork in and outside Q&R
Experienced in eMDR reporting
Experiences in reporting tools (Trackwise, SAP)
Fluent in English (verbal and written)
Problem Solving, working independently with Minimum supervision,
Handles complex Vigilance Reporting responsibilities relying on judgment and experience to determine best course of action
4+ years experience Medical Device and or other regulated industry (Pharma, IVD, ).
Basic knowledge of QSR, 21 CFR part 803, ISO13485, ISO9001, etc.