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
- 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.
- 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).
- 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.
- 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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