Regulatory Documentation Engineer (CE / FDA & Test Cases)

We Are Hiring!

Location : Vapi, Gujarat

️ Position : Regulatory Documentation Engineer (CE / FDA & Test Cases)

Experience : Minimum 3 years Industry : Medical Devices / Surgical Robotics (Preferred)

Merai Newage is currently seeking a highly skilled QA & Regulatory Documentation Engineer to join our team. This role involves the preparation of CE/FDA-compliant documentation and the development of verification and validation (V&V) test protocols for innovative surgical robotics products. The ideal candidate will be proficient in regulatory standards and test engineering processes, ensuring compliance throughout the product lifecycle.

Key Responsibilities :

Regulatory Expertise : In-depth knowledge of CE & FDA regulations, including Medical Device Regulations, ISO 13485, IEC 62304, and MDR compliance.

Technical Documentation : Creation and maintenance of essential documents such as Design History Files (DHF), Risk Management Files, and Traceability Matrices in compliance with regulatory standards.

Test Case Preparation & Execution : Develop and execute test cases for verification and validation (V&V), ensuring that products meet functional and performance specifications.

Compliance & Auditing : Support FDA, CE Marking, ISO 13485, and MDR audits, preparing necessary documentation for successful inspections.

Regulatory Submissions : Manage the preparation of 510(k) submissions, Technical Files, and other regulatory documentation for product approvals.

Risk Management : Application of ISO 14971 to assess and mitigate risks associated with medical device development.

Test Plan Development : Design comprehensive test scenarios and test cases for rigorous functional and performance testing .

Quality Management Systems (QMS) : Ensure strict adherence to QMS procedures and regulatory requirements throughout the product lifecycle.

Validation & Verification : Conduct thorough functional and performance testing to verify compliance with product specifications and regulatory requirements.

Attention to Detail : Ensure all regulatory documentation and test results are meticulously reviewed and comply with relevant standards.

Cross-functional Collaboration : Collaborate with R&D, Quality Assurance, and Regulatory teams to ensure effective communication and successful product development.

The ideal candidate will have a strong technical background in regulatory documentation, test case execution, and compliance management, with a commitment to maintaining high standards of quality assurance in the medical device industry.

To apply or refer a qualified candidate, please send your resume to .

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