Posted:1 day ago|
Platform:
Work from Office
Full Time
ROLES &
RESPONSIBILITY
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.
Bachelor s degree in a scientific discipline.
5 to 7 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.
Advanced degree (Master s/Ph.D.).
Professional certification in regulatory affairs (RAC).
Concept Medical
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