Design Controller for Medical Device domain

Summary: The role of Design Controller for the Medical Device domain involves conducting gap assessments and driving remediation activities to ensure compliance with regulatory standards. The position requires collaboration with cross-functional engineering teams and adherence to FDA, ISO, and IEC standards. This is a contract position that allows for remote work. Strong experience in the medical device industry and design controls is essential for success in this role.

Key Responsibilities:

• Perform gap assessments across Design Inputs, Outputs, V&V, and Risk Management
• Drive remediation activities to meet regulatory standards
• Work closely with cross-functional engineering teams
• Ensure compliance with FDA, ISO, and IEC standards

Key Skills:

• Strong experience in Medical Device industry
• Hands-on experience in Design Controls & Remediation
• Knowledge of standards like IEC 62304, ISO 13485, FDA 21 CFR 820
• Domain expertise in respective areas (Software / Hardware / Embedded / Cybersecurity / Validation)

Salary (Rate): undetermined

City: undetermined

Country: undetermined

Working Arrangements: remote

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other