PQV Combination Product Analyst IV

pAt Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. /p pAs guided by Our Credo, Johnson Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit. /p pbJob Function: /b Quality /p pbJob Sub Function: /b Quality Assurance /p pbJob Category: /b Professional /p pbAll Job Posting Locations: /b Beerse, Antwerp, Belgium, Little Island, Cork, Ireland, Schaffhausen, Switzerland /p pThe PQV Combination Product Analyst 4 will be responsible for handling high-volume E2E product quality complaint activities and adverse events, including performing Medical Device Reporting (MDR) assessments. Additionally, the Analyst IV Combination Products will provide instruction and feedback to the group as needed and ensure completeness and consistency of complaint and MDR documentation. The position manages and collaborates with business partners and stakeholders (Out Sourced Management Team, Clinical, PV, IT, Local Operating Companies, ESIQ, Call Centers, Brand Protection, External Manufacturing Sites, Internal/External Manufacturing Sites, QA, Business Quality, Medical Safety and RD) to deliver effective change management, drive process improvements and identify opportunities to improve the accuracy, efficiency and timeliness of the complaint and MDR processes. /p pThis may include risk assessing the impact of proposed changes to the complaint handling/MDR process within and across functional/regional areas and supporting the global change management effectively. The Analyst IV must have the ability to lead projects and communicate effectively with all levels of management as part of stakeholder engagement and change management roll out. /p h3Position duties

responsibilities:
/h3 ul liPerform high-volume end-to-end complaint handling activities, including, but not limited to: Intake, triage and review of the event reported, determination of MDR reportability, recovery of field samples for evaluation, determination of Priority/Non-Priority, and QP notification to LOC. Additional activities include due diligence to be performed with the complainant/intake centers/LOC, trend analysis, defect coding, risk criticality assessment, ensuring accurate/holistic investigation, and review and closure. /li liEvaluate complaints to determine if the QTL’s or ULC’s have been exceeded, assess the level of investigation required, and assign to the applicable site for investigation. /li liGovernance and oversight for daily thru put of complaints and MDR decisions to ensure prioritization and KPI are met. /li liPerform MDR evaluations and document written justification to support reportable and non-reportable regulatory decisions. /li liMonitor complaints for new malfunction events that may require inclusion in the malfunction description list (MDL). /li liServe as a PQV point person for post market and complaint handling regulatory/MDR questions and inquiries; provides guidance and direction to subordinate Analyst roles and other PQV functions. /li liEvaluate information from a technical perspective to ensure appropriate analysis and investigations/ MDR’s are accurately assessed for risk prioritization and performed per procedures, standards, and regulations. /li liBack-up Product Quality Vigilance Investigation Support (PQVIS) personnel to support increased volume of complaints. /li liStrong collaboration with Global Medical Safety, manufacturing sites, and LOC/BQ for effective complaint handling/MDR assessments and adverse events with potential product quality issues. /li liUse technical and product knowledge to provide accurate feedback for escalation/awareness of issues and for current product enhancements/future product development, if applicable. /li liEnsure that uniform and timely management of complaint records and regulatory reporting occurs per procedures, standards, and regulations. /li liCompile and analyze data, metrics, and trends associated with the complaint handling processes. /li liSupport internal and external audits and inspections; ability to communicate regulatory and process positions as an SME during regulatory inspections and provide follow-up support as required. /li liMay interact with regulatory authorities, other JJ operating companies, and JJ global councils to interpret and influence emerging quality systems regulatory trends. /li liProvide product wo