We are seeking a proactive and detail-oriented QA Officer to join our growing regulatory affairs and quality assurance team. The ideal candidate will have hands-on experience in the medical device regulatory landscape, with a strong understanding of CDSCO India regulatory requirements and global markets such as the US (FDA) and EU (MDR/IVDR). This role will include providing support in QMS implementation aligned with ISO 13485 standards. Required Qualifications & Skills:
- Bachelor’s or Master’s degree in Biomedical Engineering, Life Sciences, Pharmacy, or a related technical field.
- 0–1 year of relevant experience in QA/RA roles, preferably within the medical device or healthcare product domain.
- Strong working knowledge of CDSCO regulations, including the Medical Devices Rules (MDR) 2017.
- Experience in ISO 13485 QMS implementation, document control, and audit support.
- Excellent communication skills (written and verbal) and ability to engage with early-stage clients with clarity and confidence.
- Strong documentation and analytical skills; ability to work independently on multiple projects simultaneously.
Key Responsibilities: Quality Assurance & QMS:
1. Support the implementation and maintenance of ISO 13485:2016 compliant Quality Management Systems for clients (startups and SMEs).
2. Assist in documentation, training, and internal audits to ensure readiness for QMS certification audits.
3. Draft, review, and update controlled documents such as SOPs, QMS Manual, Risk Management Files (ISO 14971), CAPAs, etc.
4. Assist clients in performing gap assessments, QMS remediation plans, and compliance mapping across global requirements.
Project Management:
1. Act as the regulatory and quality liaison for clients, providing timely and clear communication on project status, regulatory feedback, and documentation needs.
2. Collaborate with cross-functional client teams (product, R&D, clinical, and operations) to ensure alignment of regulatory and quality deliverables.
3.Maintain meticulous project records, trackers, and submission logs for internal and client reporting
Pay: ₹360,000.00 - ₹450,000.00 per year
Work Location: In person
