- Maintain and improve the Quality Management System in accordance with ISO 13485 and applicable regulatory requirements.
- Ensure implementation and effectiveness of SOPs, quality plans, validation protocols, and change control processes.
- Review and approve deviations, CAPA, non-conformances, customer complaints, and risk management activities.
- Monitor quality metrics and drive continual improvement initiatives.
- Support supplier qualification, incoming quality control, in-process controls, and final release activities.
- Ensure readiness for internal, customer, certification, and regulatory audits.

Regulatory Affairs

- Manage regulatory documentation for medical devices including technical documentation, declarations, labeling, and regulatory submissions.
- Coordinate activities related to CE marking, EU MDR compliance, 510(k) support documentation, and other market-specific regulatory requirements as applicable.
- Review product labels, IFUs, packaging artwork, and promotional claims for regulatory compliance.
- Track changes in applicable standards and regulations and ensure timely implementation.

Audit & Compliance

- Lead interactions during ISO 13485, MDSAP, CE, customer, and other external audits.




- Coordinate closure of audit observations and ensure effectiveness of corrective actions.
- Ensure compliance with applicable standards such as ISO 14971, ISO 11135, ISO 10993, ISO 7886-1, and other relevant device standards.

Team & Cross-Functional Coordination

- Lead and mentor QA/RA team members.
- Coordinate with Production, Engineering, R&D;, Purchase, and Warehouse for quality and compliance matters.
- Support management review meetings and regulatory inspections.

Eligibility Criteria

Education:

- B.E./B.Tech (Biomedical, Mechanical, Chemical, Industrial or related discipline) or M.Pharm / M.Sc./B.Sc. with relevant experience.

Experience:

- 10-15 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
- Experience with sterile disposable medical devices is preferred.
- Hands-on exposure to ISO 13485, CE/EU MDR, risk management, validation, and regulatory documentation is desirable.

Pay: From ₹80,000.00 per month

Benefits:

- Versatile schedule
- Leave encashment
- Life insurance
- Provident Fund

Work Location: In person

📌 Senior Quality Analyst (Jodhpur)
🏢 Iscon Surgicals
📍 Jodhpur