Cryoport
Regulatory Engineer
Ball Ground, Georgia · Mid
Sponsorship not specifiedDetected 30 days ago
ComplianceProduct ManagementElectrical EngineeringFDA RegulatoryMedical DevicesCollaborationProblem SolvingWritingRegulatory Affairs
About the role
- MVE Biological Solutions is the leading global manufacturer of vacuum insulated products and cryogenic systems.
- More than 50 years ago, they set the standard for storage of biological materials at low temperatures.
- Today, they continue to exceed these standards.
Responsibilities
- Support design control activities, including design planning, verification, validation, design reviews, and change management.
- Maintain and support technical documentation, including DHFs, DMRs, Technical Files, and regulatory assessments.
- 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.
Requirements
- 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.
- Class II medical devices.
- Audit and regulatory inspection support.
- Join a team dedicated to innovation, quality, and regulatory excellence while helping bring life-changing technologies to customers around the world.
Nice to have
- Participate in risk management activities in accordance with ISO 14971, including risk analyses, FMEAs, and risk control verification.
- Evaluate engineering changes for regulatory, quality, and product impact.
- Assist with audits, inspections, CAPAs, investigations, and continuous improvement initiatives.
- Bachelor's degree in Engineering required (Mechanical or Electrical Engineering preferred).
- Advanced engineering degree preferred.
- Strong technical writing, problem-solving, organizational, and cross-functional collaboration skills.
- ISO 14971 risk management.
- Technical documentation and DHF management.
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