Role & responsibilities
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.
Quality and Compliance:
Ensuring compliance with the Quality and regulatory requirements
Ensure all activities are conducted in compliance with relevant regulations and best practices.
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.