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

LzhEbmNxMG9OQlNWNUJoeXppNG9jZWFwelE9PQ==
  • 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

I Saw The Sign

Social Media and Digital Marketing Coordinator Job at I Saw The Sign

 ...Social Media Policy. Email Account management, such as user creation and management, assets uploads, deactivations, etc. Email Marketing System customer service and ticket management Create and manage other digital accounts as needed Create, request, and... 

Movado Group Inc

Watch Retail Assistant Store Manager - Commission & Growth Job at Movado Group Inc

 ...Manager in San Diego to assist the Store Manager with operations, sales, and staff training. Ideal candidates should have strong sales...  .... A competitive compensation package starting at $19.50 - $23.50 per hour is offered, along with commissions. #J-18808-Ljbffr... 

Lockheed Martin

Electronics Engineer II Job at Lockheed Martin

 ...Description: Join Our Team as an Electronics Engineer where you will work on the development of a sophisticated state-of-the-art avionics product in a world class Integrated Product Development environment. Location: This position does not support teleworking... 

jobgether

Remote Events Coordinator Job at jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Project Manager - REMOTE. In this role, you will play a critical part in delivering exceptional experiences through well-executed project management and innovative solutions...

ATC Travelers A

Health Coach Specialist Job at ATC Travelers A

Join the Heart of Caregiving: Health Coach Specialist! Do you believe that home is where the heart (and the best care) is? We are looking for a high-energy, empathetic Health Coach to join our team and support our Structured Family Caregiving program.In this role...