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
