Quality/Regulatory Affairs Specialist

Custom Search Inc.; Eden Prairie (MN); On-site; USD 55,000 - 85,000; Full time

Job summary

Custom Search Inc. in Minnesota is seeking a motivated QA/RA professional to be the bridge between engineering, manufacturing, quality, and regulatory teams.

You will help ensure devices meet FDA/EU requirements and maintain comprehensive documentation while supporting global regulatory submissions. Onsite role with opportunities to grow in MedTech quality and regulatory, interacting with cross‑functional teams and external regulators.

Qualifications

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

Responsibilities

• 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

Skills

QA/RA liaison

Regulatory submissions

Documentation

Labeling compliance

Education

Bachelors in Engineering, QA, or Regulatory

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.