As a Regulatory Affairs Executive, you will ensure compliance with regulatory requirements at GPC Medical. This role is on-site in New Delhi.

Responsibilities:

• Prepare and update technical documentation as per EU MDR and 510(k) regulatory requirements.
• Prepare and update risk management and usability evaluations in compliance with ISO 14971 and IEC 62366-1.
• Prepare or review labeling, IFU, surgical techniques, and promotional materials for regulatory compliance.
• Prepare and update divisional SOPs, recommending timely changes to ensure regulatory compliance.
• Compile regulatory documents (TMF/Dossiers) for submission.
• Create design files adhering to ISO 13485:2016, MDR, and USFDA standards.
• Manage adverse event reporting to EU and other regulatory agencies.
• Develop and update risk management and usability evaluations compliant with ISO 14971.
• Prepare and revise PMS, PMCF, PSUR, and clinical evaluation files aligned with Regulation (EU) 2017/745.
• Apply knowledge and understanding of regulatory frameworks, processes, and procedures to maintain compliance.
• Monitor and improve regulatory task tracking systems and manage the team efficiently.
• Interact effectively with internal and external stakeholders (Notified Bodies, distributors, suppliers, and other regulatory authorities).

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