Regulatory Affairs Specialist

About the role

You will be part of the Regulatory Affairs department supporting global regulatory compliance and device registration processes. The ideal candidate will demonstrate strong communication skills, attention to detail, and a proactive approach.

Responsibilities

• Interact with global regulatory affairs personnel to facilitate registering or re-registering medical devices or cosmetics
• Assist with notarization, apostilling, or authentication of certificates as needed
• Support UDI database maintenance and regulatory trade compliance activities
• Support documentation and regulatory submissions to ensure compliance with applicable standards
• Become a notary to carry out specific job duties if required

Requirements

• Bachelor's degree or higher from an accredited institution (verified prior to start)
• A minimum of 2 years of regulatory affairs experience in Medical Devices, Biotech, Cosmetics, or Pharmaceuticals industries
• Experience with electronic systems such as SAP, regulatory databases, or UDI systems is preferred
• Strong communication and collaboration skills to work effectively across teams
• Ability to adapt to evolving regulatory requirements and maintain attention to detail

Qualifications

• Certified Regulatory Affairs professional (RAC) is preferred

Benefits

• Medical and Prescription Drug Plans (upon completion of waiting period)
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay

Pay

$30-35/hr on W2

Location

Maplewood, MN (on-site)

What's in it for you

• Opportunity to contribute to impactful healthcare solutions
• Engagement in a collaborative and innovative work environment
• Professional growth through diverse regulatory projects
• Participation in a dynamic team dedicated to excellence and compliance