Role & responsibilities

1. Collaboration and Documentation:

- Work closely with the NPD team to understand the product specifications and functionality to identify the documentation requirements.

- Prepare technical documentation, including product specifications documentation, design development documentation, Risk management documentation, Validation Test protocols & test reports.

- Assist in preparing and documentation alignment for CDSCO submission, EU MDR submission and FDA submission related regulatory submissions as per the requirements.

2. Quality and Compliance:

- Ensuring compliance with the Quality and regulatory requirements

- Ensure all activities are conducted in compliance with relevant regulations and best practices.

3. Test Protocols and Test Reports required for Verification and Validation:





- Preparation of the test protocols and test reports for verification and validation of the equipments as per the CDSCO, EU MDR and FDA requirements.

Preferred candidate profile

Experience in a product development setting.

- Solid analytical and problem-solving skills.

Experienced in preparing redlines for quality documents, risk management documents, verification and validation documents, supplier adoption documentation

- Excellent communication and teamwork skills.

Experienced in preparing Project Management Plans (PMP), Project Master Index (PMI).

Experience in a product development setting.

- Proficiency in 21 CFR Part 820, 21 CFR 803, ISO 13485, ISO 14971, FDA, and EUMDR regulations and standards.

- Attention to detail and ability to manage multiple projects simultaneously.

📌 Senior Executive - Documentation (NPD) (Karnataka)
🏢 Healthium Medtech
📍 Karnataka