Regulatory Analyst

Cyient

  • Pune, Maharashtra
  • Permanent
  • Full-time
  • 1 month ago
Job Description:
  • 2+ years of experience in medical device regulatory affairs EU MDR, US FDA 510(k) and closely working R&D, Quality organizations.
  • Experience creating Technical Documentation and 510(k) preparation and receiving submission approval (EU, US, Canada etc.)
  • Expertise in interpreting and implementing various medical device standards and guidance's, such as IEC 60601-1, ISO 14971-1, IEC 62366-1, ISO10993-1, and MEDDEV 2.7/4.
  • Experience with systems for quality management, product development, and follow-up of procedures is an advantage.
  • Knowledge and application of medical device QMS is required (e.g., ISO 13485, MDSAP, EU MDR, Risk Management etc.)
Personality Characteristics
  • Be able to handle ad-hoc changes in priority/planning and independently.
  • Be able to think from customer expectation perspective
  • Be able to work in different teams simultaneously
  • Communicative & disciplined team worker
Department:Healthcare and Life Sciences (India) AssociateSkills Required:Medical Devices,Medical Device Regulations,Medical Device Standards,ISO 14971 Risk Management,Product Development,IEC 62366,Documentations,Design,Technical Documents,IEC 60601Desirable Skills:Medical Devices,Medical Device Regulations,Medical Device Standards,ISO 14971 Risk Management,Product Development,IEC 62366,Documentations,Design,Technical Documents,IEC 60601Designation:Associate

Cyient