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Philips Complaints & Vigilance Reporting Specialist India, Karnataka 393466742
· Responsibility #1:
Work with a variety of diverse persons within the company such as R&D Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers, personnel to facilitate and improve the complaint handling process globally.
Global Regulatory Body Support/Liaison ‐ Collaborates with multidisciplinary groups to assist with regulatory inquiries and audits.
· Responsibility #2:
Supports Quality management System activities related to complain handling and complaint data for CAPA, Corrections and Removals (C&R), training management review and internal and external audits.
Interacts with Leaders to address Business needs related to complaint handling activities.
Enforce standardized and simplified complaint handling and adverse event reporting processes.
Establish an effective Management Review process, including routine reporting.
· Responsibility #3:
Introduce and implement complaint handling processes and tools required to ensure global regulatory compliance, quality, and patient safety.
Manages compliance to FDA regulations and other Regulatory Agencies as required.
Manages the oversight and review of complaint handling files, adverse event reports, regulatory inquiry responses, and safetyescalations.
Actively participates in inspections and questions relating to the operation of complaint handling operations, processes, and procedures in coordination with all other applicable company groups.
· Responsibility #4:
Communicates performance feedback to individuals performing complaint handling activities, ensuring consistency, quality, and adherence to defined processes related to complaint handling, adverse event reporting, and safetyescalations.
Provides expert consultation to individuals responsible for the coordination and preparation of responses to regulators and competent authority inquiries when needed.
Provides expert consultation and communicates decision making related to escalated issues for complaint handling activities, regulatory reporting decisions, requirements for additional investigation, and subject matter expert engagement.
Engages with individuals within the Businesses, Markets, and Services organization to ensure the required information for complaint handling, regulatory reporting, and/or escalations for further investigation or action are communicated and acted upon.
· Responsibility #5:
Develops and presents materials describing complaint handling and regulatory reporting KPIs, metrics, and/or daily management information to business, market, and leadership.
Facilitates conversations with technical experts to ensure timely completion of escalations. (Technical investigations, IIAs, CAPAs)
Support audits for complaint handling
You will be part of
You will be part of theYou will be able to partner with other experienced Quality team members and Leadership that will support you in the upcoming challenges and goals, and you will be able to join a very organized area where the teamwork is very much valued.
To succeed in this position, you need to have the following expertise and experience:
Bachelor degree in bio-medical, engineering, healthcare, or related technical degree with 8+ years of experience; OR Bachelor degree with 8+ years of experience in a medical device or regulated industry.
Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), EUMDR, Canadian Medical Devices Regulation (SOR/98- 282), Japanese MHLW Ordinance 169, and ISO 9001. ISO14971 Risk Management, CAPA, Previous experience in Medical device.
Product Knowledge is preferred. Project Managementcertificates(preferred).
Mandatory:Working Knowledge in the area of Complaint Handling, Vigilance reporting and its global timelines and Post Market Surveillance (PMS) for medical products.
Preferable:Knowledge of software product development, knowledge in Trackwise tool and/or Service tools. Knowledge of analytics tool/KPI trackers/Daily managements etc..
Detailed oriented, work allocation and monitoring, good communication skills, mentoring, team management, conflict management, team dynamics, self-starter, results, and targets oriented, resilience.
Advanced English required (Oral and Writing)
Our hybrid working model is defined in 3 ways:
There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
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