Regulatory Engineer

Cryoport, Inc. • Ball Ground, GA

2d

About The Position

MVE Biological Solutions is seeking a Regulatory Engineer to support regulatory compliance and product lifecycle activities for medical devices and cryogenic systems. This role partners closely with Engineering, Quality, Manufacturing, and Regulatory Affairs to ensure products are designed, documented, manufactured, and maintained in compliance with global regulatory requirements and quality standards.

Requirements

• Bachelor’s degree in Engineering required (Mechanical or Electrical Engineering 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.

Nice To Haves

• Advanced engineering degree 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level