Sr. Regulatory Engineering Specialist

Descriptio

n for  Sr. Engineering Regulatory Specialist :

Hands-on expert responsible for insuring that our products comply with evolving global technical requirements and regulations.

Responsibilities for Sr. Engineering Regulatory Specialist :

• Maintain in-depth and detailed current knowledge of all technical regulations and guidance relevant to the Organ Recovery Systems (ORS) equipment and disposable products. Regulations include, for example : IEC-60601 and all its subsidiary standards; ISO-14971, UL and TUV requirements for medical devices; IEC electrical standards, applicable ASTM standards and test methods, and the rapidly evolving FDA and European requirements for software.
• Actively monitor changes and trends in evolving medical device technical regulations.
• Actively assess and monitor continued compliance of ORS equipment and disposable as the standards and products change.
• Assess design changes for compliance to technical standards during the development process.
• Identify gaps in compliance to technical standards and then take the lead in timely correcting products and documentation to maintain conformance, either hands-on or directing others.
• Hands-on role in product testing, including developing tests, performing tests, and directing external test labs and regulatory bodies.
• Hands-on role in updating, improving, and maintaining ORS product technical documentation, including requirements and specifications, usability testing, protocols and reports for verification, and trace matrices.
• When product changes are required for compliance, provide specific technical input to engineers responsible for those design changes.
• Take the lead in developing more efficient internal processes and tools for developing and tracking technical documentation, such as automation of trace matrix linkages.
• Actively educate other members of staff on applicable technical regulations.

Requirements for Staff Electrical  Engineer :