– Develop regulatory strategies for new/existing products.
– Ensure compliance with local/international regulations (CDSCO, ISO, FDA).
– Prepare and submit regulatory submissions.
– Monitor regulatory developments and adjust strategies.
– Liaise with regulatory bodies and internal teams for compliance.
– Conduct audits and maintain up-to-date knowledge of regulatory requirements.
Required Qualifications:
– Bachelor’s degree in a scientific discipline.
– 2 to 3 years’ experience in regulatory affairs within the medical device industry.
– In-depth knowledge of CDSCO, ISO, FDA standards.
– Experience with regulatory submissions and medical device development.
– Excellent communication, organizational, and project management skills.
Preferred Qualifications:
– Advanced degree (Master’s/Ph.D.).
– Professional certification in regulatory affairs (RAC).
