GPC Medical Ltd.
Website:
gpcmedical.com
Job details:
🚨 We’re Hiring | RA Executive
Location: Delhi
Experience: 2–3 Years
Department: Regulatory Affairs
GPC Medical Ltd. is looking for a Regulatory Affairs (RA) Executive to join our team. The ideal candidate should have hands-on experience in regulatory documentation, QMS, audits, risk management, and medical device registration.
Key Responsibilities
- Prepare, review, and implement Quality Management System (QMS) procedures.
- Prepare and maintain Technical Files for medical devices.
- Conduct and coordinate Supplier Audits and Internal Audits.
- Prepare and maintain Risk Management, PMCF, CER, Product Descriptions, and other regulatory documents.
- Prepare and review the Master List of Documents, Master List of Records, Obsolete Document List, CAPA, Change Control, and related QMS documentation.
- Assist in preparing regulatory dossiers for product registration in domestic and international markets.
- Ensure regulatory documentation is accurate, updated, and compliant with applicable requirements.
- Coordinate with internal teams to support regulatory submissions and compliance activities.
Candidate Profile:
- 2–3 years of relevant experience in Regulatory Affairs, preferably in the medical device/healthcare industry.
- Graduate/Postgraduate in Pharmacy, Life Sciences, Biotechnology, Medical Devices, or a related field.
- Good understanding of QMS, Technical Files, Risk Management, CER, PMCF, CAPA, and Change Control.
- Knowledge of medical device regulatory requirements and registration processes.
- Strong documentation, analytical, and coordination skills.
- Good written and verbal communication skills.
- Strong attention to detail and ability to manage regulatory documentation within timelines.
Interested candidates can share their CV at hr@gpcmedical.com or click the apply button
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Click on Apply to know more.
