Sahana Shezhiyan

Regulatory and Quality Affairs

• 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.

Bachelors degree in Business Management