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Responsibilities:Prepare, review, and maintain regulatory documentation including technical files and declarations of conformity.Assist in regulatory submissions for international markets (EU MDR, FDA 21 CFR Part 820, etc.).Ensure compliance with ISO 13485, ISO 14971, and applicable standards.Support internal teams with regulatory guidance during product development and lifecycle management.Contribute to risk management activities and quality system processes.Stay up-to-date with changes in…
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