MedTech QA/RA Specialist — Growth & Global Compliance

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

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.