HCLTech is seeking a Complaints Handling Analyst for its Medical Devices Program in Madurai. The ideal candidate will have experience in medical device complaints handling or Post-Market Surveillance (PMS) activities.
Key Responsibilities:
- Manage and process complaints related to medical devices.
- Ensure compliance with global medical device regulations such as CFR Parts 803, 806, 820, ISO 13485, ISO 14971, and EU Medical Device Directives/Regulations.
- Investigate and document complaints, ensuring timely resolution.
- Collaborate with cross-functional teams for root cause analysis and corrective actions.
- Maintain accurate records and generate reports for regulatory submissions.
- Communicate effectively with stakeholders, both written and verbal.
Required Skills & Qualifications:
- 3+ years of experience in medical device complaints handling or PMS.
- Strong knowledge of medical device regulations (FDA, ISO, EU MDD/MDR).
- Excellent communication and documentation skills.
- Ability to work in a fast-paced, compliance-driven environment.
About HCLTech
HCLTech is a global technology company with a strong presence in IT services, engineering, and healthcare solutions. With a focus on innovation and compliance, HCLTech works with leading medical device manufacturers to ensure product safety and regulatory adherence.
How to Apply?
Interested candidates meeting the criteria can share their profiles to:
Email: prishika.j@hcltech.com
