Regulatory Engineer

Company : Cryoport Systems, Llc.

Job Type : Full Time

9300 Kirby Dr, Ball Ground

Number of Applicants

000+

Apply Now

Let AI Supercharge Your Job Hunt!

JobCopilot scans 500,000+ company career sites daily to find jobs for you

Never miss an opportunity Save hours by auto-filling applications forms Land more interviews with tailored applications

Activate JobCopilot

Job Description - Regulatory Engineer

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.

Original job Regulatory Engineer posted on GrabJobs ©. To flag any issues with this job please use the Report Job button on GrabJobs.

Apply Now

Auto-Apply to Similar Jobs

Share Job

Get your Resume Reviewed for Free

Automate Job Applications for Similar Jobs

Auto-Apply to Regulatory Engineer Jobs with your AI JobCopilot

Auto-Apply with AI

Similar Regulatory Engineer Jobs in the US

Get your Resume Reviewed for Free

Email address

Why are you reporting this job?

I think it’s a discriminatory or offensive

I think it’s fraudulent or a scam

I think it’s trying to sell something unrelated to the job / it’s asking for money

I think it contains incorrect or broken information

Other

All Job Ads are subject to GrabJobs’s Terms of Service. We allow users to flag postings that may be in violation of those terms. Job Ads may also be flagged by GrabJobs moderation team. However, no moderation system is perfect, and flagging a posting does not ensure that it will be removed.

Setup your job alert:

Frequency

By activating job alerts, I agree to GrabJobs Terms & Privacy Policy. I can unsubscribe to job alerts anytime. Skip

Regulatory Engineer

Job Description - Regulatory Engineer

Similar Regulatory Engineer Jobs in the US

Mobile Apps