Quality/Regulatory Affairs Specialist Job at Custom Search Inc., Eden Prairie, MN

V2ZKU3BST0t5MjZhODhoYkZBdU0rN29kVmc9PQ==
  • Custom Search Inc.
  • Eden Prairie, MN

Job Description


We have partnered with a small start-up company that is looking for someone who’s hungry to grow, ready to learn, and excited to be at the center of product quality and regulatory excellence.

In this role, you’ll be the bridge between engineering, manufacturing, quality, and regulatory teams, helping ensure their devices meet the highest standards and are ready for global markets. If you love variety, impact, and being part of a company that’s building meaningful technology, this is your opportunity.

Your role with the company:


* Support product development with hands-on Quality Systems guidance
* Contribute to regulatory submissions and compliance activities
* Maintain master files, technical documentation, and our standards library
* Review labeling and ensure it meets FDA/EU/global requirements
* Help manage our complaint-handling system
* Partner with teams across the company and with FDA, Notified Bodies, and external experts

Why You’ll Love It:


You’ll gain exposure to everything : QS strategy, documentation, labeling, compliance, international standards, and real regulatory interactions. This is the perfect role for someone early in their career who wants to level up fast in QA/RA.

Desired Profile:


• 1+ year in medical devices OR engineering/startup experience
• Strong research skills and curiosity to learn
• Ability to work independently and proactively
• Onsite presence required (not a remote role)

If you’re motivated, detail-oriented, and excited to build your career in MedTech quality and regulatory, this role will open doors.

Job Tags

Similar Jobs

Thomas J Henry Injury Attorneys

Litigation Attorney Manager Job at Thomas J Henry Injury Attorneys

Litigation Attorney Manager *Position Overview**Location* San Antonio, Corpus Christi...  ...and supplemental insurance. Relocation assistance (if applicable). Career advancement...  ...community involvement initiatives. *Why Join Us* We are a results-driven firm that... 

Inergroup Insourcing Solutions

Warehouse Packer - Hiring Immediately Job at Inergroup Insourcing Solutions

 ...Hiring Immediately - Warehouse Packer - Acworth, GA: Inergroup is hiring immediately for Warehouse Packer jobs in Acworth, GA. As a...  ...available! Skills and Qualifications: No prior warehouse experience is required; we welcome entry-level candidates. Ability to... 

Syneos Health Careers

CRA II | Sponsor Dedicated | Oncology (Home-Based - Buffalo, NY) Job at Syneos Health Careers

 ...Description CRA II | Sponsor Dedicated | Oncology (Home-Based - Buffalo, NY) Syneos Health is a leading fully integrated biopharmaceutical...  ...activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology... 

Oscar

Junior Estimator Job at Oscar

 ...Job Description Junior Estimator - Site Development & Civil Projects - Central Texas The Role An industry-recognized general contractor with deep Texas roots is looking to bring on a Junior Estimator to support its expanding preconstruction efforts. This... 

Cooper Heating & Cooling, Inc.

Appointment Setter Job at Cooper Heating & Cooling, Inc.

Job Description Job Description As a member of our team, you will staff our kiosk at a Costco Warehouse as an ambassador and promote Cooper Heating and Cooling. With a strong focus on customer service and a commitment to integrity, you will answer questions and assist...