Regulatory Compliance Jobs | ICU Medical Analyst Role Chennai
If you’re seeking regulatory compliance jobs that blend quality, patient safety, and innovation, ICU Medical offers an exceptional opportunity in Chennai. The Analyst, GCM Vigilance Reporting role is perfect for professionals passionate about maintaining global compliance and ensuring the highest safety standards in the medical device industry. This clinical research job also offers exposure to quality systems and vigilance reporting, making it a great fit for those pursuing quality analyst jobs in one of India’s leading healthcare hubs – Chennai.
Regulatory Compliance Jobs Detail
- Job Position: Analyst, GCM Vigilance Reporting
- Department: Quality
- Location: Chennai, Tamil Nadu, India (Hybrid)
About the Company
ICU Medical is a global leader in developing and manufacturing advanced medical devices used across infusion therapy, oncology, and critical care. With a strong focus on regulatory compliance and patient safety, the company provides meaningful career paths for those seeking regulatory compliance jobs in healthcare. Working at ICU Medical means contributing to a culture that values innovation, quality, and integrity in every aspect of healthcare delivery.
Qualifications & Skills
Education & Experience:
- Required: Graduate in Medical Engineering or Allied Science.
- Preferred: Bachelor’s in Clinical Laboratory Science. Experience in healthcare environments or quality/compliance roles within FDA-regulated industries preferred.
Job Description
As an Analyst, GCM Vigilance Reporting, you will play a crucial role in managing global medical device and pharmaceutical complaints, ensuring adherence to international regulatory compliance standards. This clinical research job involves the evaluation of safety data, triaging complaint files, and coordinating with internal quality teams to ensure accurate and timely submissions. You’ll work closely with cross-functional departments to maintain product safety and enhance reporting efficiency.
Key Responsibilities for this Regulatory Compliance Jobs
- Evaluate complaints from a patient safety perspective and determine reportability per global requirements.
- Create and submit regulatory reports to the FDA and Regional Competent Authorities.
- Ensure all reports comply with international regulatory compliance standards.
- Manage complaint life cycles, including sample retrieval, investigation, and closure.
- Escalate and address customer advocacy issues promptly.
- Communicate effectively with internal and external stakeholders to ensure accuracy in reporting.
Knowledge, Skills, and Competencies:
- Understanding of medical terminology and clinical product applications.
- Strong analytical skills for complaint and adverse event evaluation.
- Excellent communication and teamwork abilities.
- Experience in quality analyst jobs or clinical research jobs is advantageous.
