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. Industries from around the world look to MVE for excellence and innovation. Their solutions empower industries to better utilize cryogenic technology. In this manner, MVE continues to make a vital contribution in today’s biomedical life sciences industry.
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.
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 Experience
* 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.
Join a team dedicated to innovation, quality, and regulatory excellence while helping bring life-changing technologies to customers around the world.
