Job available - immediate employment - Regulatory Affairs Specialist - Whip Mix - Whip Mix
- English
- Español
- Job Search
- Create Account
- Log In
- Help
Whip Mix
- Whip Mix
- Job Search
- Create Account
- Log In
- Help
- English
- Español
Decline Match
Reason --SELECT-- Great job, wrong time Job Match does not fit my Profile Missing a key benefit No interest in company Other (Please Specify) Over-Qualified Salary too low Under-Qualified
Brief Explanation
OK Cancel
Job Description
Regulatory Affairs Specialist
Louisville, KY, United States of America
$70,000.00 - $80,000.00
Back Apply Now
Back
Apply Now
Overview
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 company with 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.
Job Skills / Requirements
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 Plan
This is a Full-Time position
Back Apply Now
Back
Apply Now