Officer - Regulatory Affairs

Location: Verna - Goa
Job ID: 006
Department : Quality Assurance


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

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