Divine meditech private limited is looking for one detail-oriented and experienced Quality & Regulatory Officers to join our team. The ideal candidates will be responsible for ensuring that our medical devices and drug products meet all national and international regulatory standards. You will play a key role in maintaining compliance, managing documentation, and ensuring the highest quality standards.

Key Responsibilities

- Regulatory Compliance: Manage and ensure compliance with EU MDR, FDA regulations, and other statutory requirements for medical devices and drugs.
- Quality Management: Implement and maintain QMS (Quality Management Systems) in accordance with ISO 13485 and ISO 9001.
- Quality Control: Oversee QC processes to ensure products meet defined specifications and safety standards.
- Documentation: Prepare, review, and submit regulatory filings, technical files, and dossiers.
- Technical Knowledge: Strong understanding of EU MDR, ISO 13485, ISO 9001, and FDA guidelines.

Job Type: Full time Pay: ₹30,000.00 - ₹60,000.00 per month

Benefits

- Health insurance
- Provident Fund

Work Location: In person

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