What are the responsibilities and job description for the Medical Device & Regulations Engineer position at Katalyst CRO?
Responsibilities
- Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.
- Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software.
- Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards.
- Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11.
- Creation and review of validation deliverables including but not limited to
- Requirement Specifications (User, Functional.
- Plan
- Qualification Protocol (Installation, Operational, Performance)
- Reports (Summary, Exception) of protocol execution� Traceability Matrix.
- Periodic Reviews.
- System Retirement/Decommissioning.
- Execution of Dry/Test protocol run.
- Conduct Periodic Reviews to determine if the system is in a validated state and take appropriate actions.
- Perform System Retirement/Decommissioning of systems not in business
- Work closely with software development and IT teams to establish best practices for quality and compliance.
- Provide expertise and guidance on quality assurance processes for non-product software to ensure robust software management.
- Drive continuous improvement initiatives in software development processes, ensuring alignment with the company's quality management system.
- A Minimum bachelor's degree in engineering, Science or related technical field.
- Minimum of 4-5 years of experience in software quality assurance or software validation, preferably within the medical device industry.
- Strong understanding of quality standards and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
- Experience with non-product software validation, including tools for development, testing, and maintenance.
- Good knowledge and experience of CSV activities but not limited to:
- GxP and 21 CFR Part 11 applicability/criticality assessment.
- Identification, Preparation and Review of validation deliverables such as Requirements, Plan, Protocols, Test specifications, Reports, Traceability Matrix etc.
- Execution of Dry/Test protocols� Conduct Periodic Reviews of systems
- Perform System Retirement of systems that are not in business
- Understanding of Medical Device Quality and Compliance
- Good knowledge of GxP, GAMP and 21CFR Part 11 guidelines
- Working experience in Product Lifecycle Management (PLM) tool.
- Sound knowledge of computer system development lifecycles.
- Knowledge of JIRA, JAMA software and test automation is a plus.
- Key Words to search in Resume Computer System Validation, 21 CFR Part 11, GxP, FDA, 21 CFR Part 11, ISO 13485, IEC 62304.
