Regulartory Affairs

• Coordinate with external test labs for safety/compliance test
• Preparation and compilation of Technical Files for regulatory submission
• Classification of Medical Devices based on USFDA, TPD, MDD, PAL and other National/Regional regulations
• Identification of ‘Substantially Equivalent’ devices with proper justification
• Support QAD for QMS process improvement activities and during internal/external audits
• Interpretation of standards’ requirement statements and assist Project team to derive design requirement statements
• Effort and timeline estimation for regulatory activities for project planning
• Identification of applicable safety and compliance tests
• Support Project teams for DHF and DMR preparations
• Creating awareness to Design Engineers on Medical Device Regulations, through facilitation, conducting training programs
• Identification of applicable regulatory standards and requirements for said Medical devices
• Participate in review meetings to ensure Regulatory compliance in project deliverables

Yêu cầu công việc

• As Auditee faced auditing by independent agencies like Govt body, TUV, BSI, DNV, UL
• Good interpersonal skills
• Working experience in healthcare institute (hospital/test lab) for installation, training and maintenance of Medical devices/IVD devices
• Graduate in Science or Engineering (Bio-Medical, Electrical, Electronics, Mechanical)
• Extensive knowledge on QMS standards like ISO 9001, IATF 16949 (ISO/TR), ISO 22000, ISO 13485
• Extensive experience in Incoming, in-process and/or final inspection
• Working experience as Management Representative (MR) in ISO certified company.
• Good understanding of CAPA lifecycle and root-cause analysis and techniques involved
• Lead Auditor or Internal Auditor training in any of the QMS standard will be an added advantage
• Green/Black belt in Six sigma
• Ability to work in a timeline driven environment
• Contributed for Quality Management System by authoring processes, implementation and/or training for effective implementation
• Total working experience: 8-10 Yrs. Relevant experience: 6+ Yrs

100% salary in probation period
18 leaves per year
Premium Health Insurance service for Employee and Family

Cập nhật gần nhất lúc: 2021-12-15 09:22:02