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Sahana Shezhiyan

Sahana Shezhiyan

Regulatory and Quality Affairs

Administrative

Woodlands

Social


About Sahana Shezhiyan:

Regulatory and Quality Affairs

Experience

  • Responsible for the preparation and documentation of regulatory submissions to H.S.A and Sri Lanka Distributors according to ASEAN CSDT.
  • Work closely with regional RA & Global to drive reduction of registration cycle time through Speed to

Market initiatives.

  • Define and implement product registration approval strategies and plans.
  • Manage product approval process and responsible for clearing approval and other barriers to
  • Ensure timely market release of new products with appropriate licenses.
  • Update significant and comprehensive commentary report on a monthly, quarterly and yearly

Basis

  1. Regulatory Operations
  • Maintain a 12-month regulatory plans, renewals and new submissions
  • Maintain databases of all submissions and approvals.
  • Support internal systems and processes, relating to regulatory and quality, e.g. International
  • Registration Requests (IRR), Change Notifications, SAP, GTS
  • Oversee and ensure development, implementation and compliance of relevant SOPs and execute Regulatory operations such as Global Distribution Regulatory Controls and Regulatory Information Management System.
  1. Regulatory Compliance
  • Oversee copy review advertising and promotional materials and relevant internet activities and

publications to comply with all relevant internal policies and local country regulations.

  • Responsible for adverse event and field safety corrective action/ product recall reporting and timely

closure with the regulatory authority.

  • Manage the implementation of Good Distribution Practices for Medical Device (GDPMD).
  1. New and Changing Regulatory Environment
  • Understand and help influence medical device regulatory environments by leveraging key relationships

with the Authority and with industry groups.

  • Proactively work with the government officials and other agencies in resolving pre and post-market

registration issues.

  • Provide assessment of the new and changing regulations for any impact. Outline the plan for mitigation of impact, communicate to stakeholders and implement.
  1. Quality
  • Participate in Internal, Corporate and External Audits such as CAB (Conformity Assessment Body).
  • Assist QA in the management of product complaints and execution of field safety correction action and related activities.
  • Manage the SOP, WI and the overall QMS (Quality Management System) of the organization.

Education

Bachelors degree in Business Management

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