Bio medical Engineer and Regulatory compliance Manager (Bengaluru)

Bio medical Engineer and Regulatory compliance Manager (Bengaluru)

16 Oct
|
NEOKRAFT MEDICAL PVT.LTD
|
Bengaluru

16 Oct

NEOKRAFT MEDICAL PVT.LTD

Bengaluru

Qualification: Diploma / B.E. / B.Tech in Biomedical Engineering, Electronics, or a related discipline.

Responsibilities:

- Installation, demonstration, servicing, and preventive maintenance of medical equipment.
- Troubleshooting electronic and electromechanical systems.
- Providing technical support and equipment training to hospital staff.
- Maintaining service reports and installation records.
- Coordinating with production and quality teams to resolve technical issues.

Preferred: Experience with infant warmers, incubators, phototherapy units, and neonatal care equipment. Good communication skills and willingness to travel. 2. REGULATORY AFFAIRS & COMPLIANCE EXPERT — MEDICAL DEVICES

Qualification: Degree in Biomedical Engineering, Pharmacy, Life Sciences, or a related discipline.

Responsibilities:

- Managing medical device licensing applications, renewals, and regulatory submissions.
- Preparing and maintaining technical documentation,



Device Master Files, and Plant Master Files.
- Supporting ISO 13485 quality management systems, internal audits, and certification audits.
- Handling SOPs, document control, CAPA, complaints, and change control.
- Coordinating product testing, risk management documentation, and applicable standards compliance.
- Liaising with regulatory authorities, laboratories, and certification bodies.

Preferred: Hands-on experience with CDSCO requirements, Indian Medical Devices Rules, ISO 13485, and medical electrical equipment documentation. Experience: Relevant medical device industry experience preferred.

Pay: ₹20,000.00 - ₹35,000.00 per month

Advantages

- Cell phone reimbursement
- Commuter assistance
- Provident Fund

Work Location: In person

📌 Bio medical Engineer and Regulatory compliance Manager (Bengaluru)
🏢 NEOKRAFT MEDICAL PVT.LTD
📍 Bengaluru

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