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Job details:
About the Role:
We are looking for a hands-on Regulatory Affairs & QMS Executive to take ownership of our end-to-end regulatory and quality systems for medical devices.
This is not a support role — you will be expected to drive documentation, identify gaps, recommend improvements, and work towards obtaining CDSCO manufacturing licenses.
Key Responsibilities:
• Prepare, review, and manage DMF, PMF, and technical documentation
• Develop and maintain ISO 13485 QMS documentation
• Handle CDSCO applications (MD-5, etc.) and query responses
• Conduct internal audits and ensure compliance readiness
• Identify gaps in documentation/processes and recommend practical, cost-effective solutions
• Coordinate and support ISO and CDSCO audits
• Oversee and guide validation activities (sterilization, packaging, shelf-life, biocompatibility, etc.)
• Maintain risk management documentation (ISO 14971)
• Provide strategic and practical recommendations to stakeholders on regulatory, compliance, and validation approaches
Requirements:
• 1–3 years of experience in medical device regulatory/QMS
• Exposure to ISO 13485 documentation and audits
• Experience with CDSCO submissions/applications
• Basic understanding of:
• Risk Management (ISO 14971)
• Sterilization (ETO – ISO 11135)
• Packaging (ISO 11607)
• Ability to work independently and take ownership
• Strong attention to detail and problem-solving mindset
What We’re Looking For:
• Someone who can think beyond templates
• Ability to review and improve existing documentation
• Willingness to take responsibility and grow into a leadership role
Click on Apply to know more.