Analyst
HCL Technologies
IT
Job Summary
To understand the design specifications| conduct analysis| deliver the results of analysis done on it as per the defined quality and time standards and suggest design modification as per requirement.
Job Position: PMS Analyst – Medical Devices Complaints Handling
Job Description: To handle medical device customer allegations in complaints management system . Candidate with knowledge on Medical devices usage, Complaint Evaluation, Investigation, Medical devices reporting including post-market surveillance (PMS) and CAPA.
Roles and Responsibilities:
• To work on Complaint handling Process – Evaluation, Regulatory Assessment
• Work with lead in completing daily assignation.
• Organize and manage daily work allocation
• Complaints remediation using work instruction, compliance to process
• To drive Efficiency and compliance.
• Collaborate with of cross function team (CFT) Daily status to lead associate
Skills:
• 2 to 4 years of experience in Medical devices complaints handling or any PMS activities
• Working knowledge of appropriate global medical device regulations, requirements, and standards such as: CFR Parts 803, 806 and 820, ISO 13485, ISO 14971, EU Medical Device Directives/Regulations including MEDDEV Guidelines
• An excellent communicator, both written and verbal
• Adopt to cross cultural differences
• Ability to work in a timeline driven environment
• Proficiency using tools such as Trackwise, Sales force, Service Max
Educational Qualification: B.E./B.Tech (Bio-Medical, Mechanical), B.Pharm, BSc Bio Science
Total working experience (TEX): 2 to 4 years
Relevant experience (REX): 2+ years
Search words: ISO 13485, USFDA, Regulatory, QSR, Part 820, Medical Devices, Complaints Handling, post market surveillance, PMS
Target companies: Baxter, BD, TCS, WIPRO, Tech Mahindra, Amgen, HCA Healthcare, Cyient, HTC Global Software, Medtronic any medical devices company with complaint handling experience
Position location: Chennai or Madurai
Joining L4:
Key Responsibilities
2. To validate the results and prepare the reports.
3. To prepare the model for the analysis and build technical model.
4. To perform the quality checks throughout the process.
5. To gather information and to prepare the methodology for the analysis.
Skill Requirements
Other Requirements
Why HCLTech?
At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first.
HCLTech is a global technology company, home to more than 226,300 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending December 2025 totaled $14.5 billion.
