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: <CU L4 will provide)
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.