Coordinate and prepare technical files for submission to regulatory bodies with appropriate input from supporting functions (R&D, Quality, Manufacturing, Medical Affairs, etc.).
l Responsible for review and maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations.
l Coordinates the creation and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department.
l Undergraduate or postgraduate in life science, engineering, or related technical field; advanced degree preferred. Regulatory Affairs Certification preferred.
l Coordinate with applicable stakeholders, to support submissions as per requirements.
l Coordinate to comply with new regulations and international standards.
l Remain current on regulations affecting in vitro diagnostics product and keep the relevant team and supervisors informed about potential impact.
l Carry out the above tasks with limited supervision
Two to Three
year experience of regulatory, development, clinical affairs, or quality
assurance in Medical Device/ In Vitro Diagnostics or similar industry a plus.
2 - 3 years