Job Description

Regulatory Affairs Specialist

Whip MixLouisville, KY

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At Whip Mix, innovation isn’t just what we do—it’s who we are. For over a century, we’ve been a trusted partner to dental professionals worldwide. From designing and manufacturing cutting-edge digital solutions to tried-and-true lab essentials, we bring craftsmanship, technology, and customer care together in one place.

We’re proud to be a family-owned, Louisville-based companywith a global reach, serving dental labs, universities, and clinicians across more than 80 countries. Our mission? To combine quality and creativity with a service-first mindset that makes a real difference in people’s lives. If you’re looking to join a team where tradition meets innovation, and where every day brings new opportunities to grow, Whip Mix is the place for you.

We’re looking for a Regulatory Affairs Specialist to support the development, documentation, and compliance of medical device products across global markets. In this role, you’ll be a key partner to Quality, R&D, and Operations and ensuring our products meet regulatory standards from concept through commercialization.

What you'll be doing:

• Support preparation and maintenance of regulatory and quality documentation in alignment with global requirements (FDA, ISO 13485, MDR, MDSAP, and beyond)
• Assist with Certificates of Conformance (CoC), Certificates of Foreign Government (CFG), and Declarations of Conformity (DoC)
• Prepare and maintain documentation for 510(k) submissions and international regulatory filings
• Maintain Medical Device Files and ensure documentation is current within the QMS
• Support product registrations and renewals with international partners
• Coordinate and maintain quality agreements, including tracking renewals and updates
• Ensure product labeling and documentation meet regulatory requirements across the U.S., EU, Canada, Australia, and other global markets
• Create, update, and validate product labels for medical and non-medical devices
• Verify UDI information, safety statements, hazard warnings, and required regulatory symbols
• Partner cross-functionally to ensure new and modified products meet regulatory and quality standards
• Develop and maintain validation documentation (protocols, reports, supporting records)
• Support process validation activities and maintain the master validation list
• Assist in investigating product complaints and quality issues
• Support root cause analysis and initiate Corrective Action Requests (CAR/CAPA) when needed
• Maintain complaint tracking logs and support cross-functional communication
• Support internal and external audits
• Assist with responses to regulatory inquiries and audit findings
• Help maintain a state of continuous inspection readiness

What you'll bring to the table:

• Bachelor’s degree in a technical or engineering field or equivalent experience
• 2–3 years of experience in Quality Assurance or Regulatory Affairs within a Class I or II medical device environment
• Experience supporting regulatory documentation and medical device files preferred
• Familiarity with FDA regulations, ISO 13485, MDR, and MDSAP
• Strong documentation skills and exceptional attention to detail
• Advanced proficiency in Microsoft Excel and Word
• Ability to work cross-functionally and manage multiple priorities

Education Requirements (All)

BA/BS in Engineering or Equivalent

Additional Information/Benefits

Benefits: Medical Insurance, Life Insurance, Dental Insurance, Vision Insurance, Paid Vacation, Paid Sick Days, Paid Holidays, 401K/403b PlanApply

Job Tags

Worldwide

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