Qualifications:
- 3-5 years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related highly regulated industry.
- Knowledge of medical safety environment and regulation.
Essential Duties and Responsibilities:
- Document and review malfunction MDR data fields and potentially Vigilance Reports (i.e. MDV, MPR) as required. This includes providing the completed data fields to Medical Safety to support on-time filing of initial and supplemental regulatory reports.
- Evaluate reportable regulatory decisions to ensure accuracy and document written justification to support reportable regulatory decisions.
- Perform end to end complaint handling activities for Combination Products as requested.
- Serve as a PQV (Product Quality Vigilance) point person for post market and complaint handling regulatory questions and inquiries.
- The position collaborates with business partners and stakeholders (Outsourced Management Team, Internal/External Manufacturing Sites, Clinical, PV, IT, Local Operating Companies, ESIQ, Call Centers, Brand Protection, QA, Business Quality, Global Medical Safety and R&D) to drive process improvements and deliver effective change management.
- Assist with various projects within the department and communicate effectively with all levels of management.
Educational Attainment: Bachelor's degree or Master's degree (preferred) in technical, scientific, or engineering disciplines required. Biomedical Engineer, Registered Pharmacist, Registered Nurse, Physician Assistant or similar healthcare provider/science license/certification/degree preferred
Work Schedule: Day Shift
Work Location: Paranaque City/Work from Home
