Regulatory Engineer

Key Responsibilities

• Support design control activities, including design planning, verification, validation, design reviews, and change management.
• Participate in risk management activities in accordance with ISO 14971, including risk analyses, FMEAs, and risk control verification.
• Maintain and support technical documentation, including DHFs, DMRs, Technical Files, and regulatory assessments.
• Evaluate engineering changes for regulatory, quality, and product impact.
• Support design transfer and manufacturing implementation activities.
• Collaborate with cross-functional teams to ensure compliance with FDA, ISO 13485, EU MDR/MDD, and other applicable regulations.
• Assist with audits, inspections, CAPAs, investigations, and continuous improvement initiatives.

Qualifications

• Bachelor’s degree in Engineering required (Mechanical or Electrical Engineering preferred). Advanced engineering degree preferred.
• Experience in a regulated industry, preferably medical devices.
• Working knowledge of FDA regulations, ISO 13485, EU MDR/MDD, design controls, risk management, and change control processes.
• Strong technical writing, problem-solving, organizational, and cross-functional collaboration skills.
• PREFERRED: Class II medical devices. ISO 14971 risk management. Technical documentation and DHF management. Regulatory impact assessments and engineering change control. Audit and regulatory inspection support.