Officer - Regulatory Affairs Job in North Goa at Molbio

Molbio is hiring for the role of Officer - Regulatory Affairs!

Responsibilities of the Candidate:

• Coordinate and prepare technical files for submission to regulatory bodies with appropriate input from supporting functions (R&D, Quality, Manufacturing, Medical Affairs, etc.).
• Review and maintenance of product technical files and ongoing activities related to compliance with Global Regulatory directives and regulations. 
• Coordinate the creation and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department.
• Coordinate with applicable stakeholders, to support submissions as per requirements.
• Coordinate to comply with new regulations and international standards. 
• Remain current on regulations affecting in vitro diagnostics products and keep the relevant team and supervisors informed about the potential impact.
• Carry out the above tasks with limited supervision

Requirements:

• Undergraduate or postgraduate in life science, engineering, or related technical field; advanced degree preferred. Regulatory Affairs Certification preferred.
• Two to Three years of experience in regulatory, development, clinical affairs, or quality assurance in Medical Device/ In Vitro Diagnostics or similar industry a plus.