Vigilance Reporting Specialist_at Philips
Location
Pune
Job Description
In this role, you have the opportunity to Be part of the complaint handling transformation, which will help improve the lives of millions of people while advancing Philips’s journey as a global leader in Health Technology.
You will use your experience to ensures timely global medical device reporting by assessing complaints against global reporting requirements and facilitating any required further investigation. You will write and submit medical device reports (MDRs) and /or regulatory reporting.
You are responsible for
- Works with a variety of diverse persons within the company such as Complaint Investigators, PMS Clinical Experts, CH Market Experts, Engineers, Scientists, Field Service & Application Engineers and Manufacturing personnel to facilitate reportable device events in accordance with written procedures and global reporting requirements.
- Utilizes global decision trees and country specific exemptions to determine worldwide complaint reporting requirements and serious public health threat applicability in accordance with written procedures and global reporting requirements
- Collaborates with Level 3 complaint investigator to determine the need for Clinical Assessment and Clinical Harm Review.
- Provides review of complaint to ensure all information needed for Reporting/MDRs is present; determine if further investigation is needed and track investigation to conclusion.
- Writes MDRs/MIR reports and submits to the necessary authorities
- Monitors and improves tracking/control systems for medical device reporting
- Investigates and prepares responses to address Competent Authority inquiries and provide follow-up
- May perform complaint investigation activities upon request
- May perform other duties as assigned
You are a part of
You will be part of the Post Market Surveillance Team, a young, dynamic and multicultural team. Your main area will be IGT Systems.
To succeed in this role, you’ll need a customer-first attitude and the following
– Bachelor’s Degree or higher in biomedical engineering, science, healthcare, or medical profession (Associates degree may be considered for individuals with at least 5 years hands‐on patient care experience or experience with servicing or supporting the product(s) or similar product(s) in the field)
– 6+ years’ experience Medical Device and or other regulated industry
– Basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO1497, and ISO9001
– Global post market surveillance regulation (21CFR, MDD93/42/EEC and other applicable global regulations), ISO14971 Risk Management.
– Product Knowledge of IGT-S products is preferred.
– Good Verbal and written communication skills.
– Analytical skills and focus on detail.
– Teamwork in and outside Q&R.
– Fluent in English (verbal and written)
