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).
