Regulatory Lead

  • Experience Range: 6-8 years
  • Job Location: Hanoi
  • Duty & Responsibilities:

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

  • Reqirements:

    – Extensive knowledge on QMS standards like ISO 9001, IATF 16949 (ISO/TR), ISO 22000, ISO 13485 – Working experience as Management Representative (MR) in ISO certified company.
    – Contributed for Quality Management System by authoring processes, implementation and/or training for effective implementation
    – Extensive experience in Incoming, in-process and/or final inspection
    – Working experience in healthcare institute (hospital/test lab) for installation, training and maintenance of Medical devices/IVD devices
    – As Auditee faced auditing by independent agencies like Govt body, TUV, BSI, DNV, UL
    – 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
    – Good interpersonal skills
    – Ability to work in a timeline driven environment
    – Educational Qualification: Graduate in Science or Engineering (Bio-Medical, Electrical, Electronics, Mechanical)
    – Total working experience: 8-10 Yrs. Relevant experience: 6+ Yrs

  • Benefit:

    – Salary up to 1500$
    – Insurance plan based on full salary + 13th salary + Performance Bonus.
    – 100% full salary from the 1st day of working and during WFH. Medical Benefit (Bao Viet Insurance package) for Employee and Family.
    – Working in a fast paced, flexible, and multinational working environment. Chance to travel onsite (in 49 countries).
    – Internal Training (Technical & Functional). Scope of English Training.
    – Working time: 8:30 am-6:00 pm from Mondays to Fridays.
    – 18 paid leaves per year (including 12 annual leaves + 6 personal leaves)

  • Preferred Language for Application: English

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