Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Customer Support/Service, Dental Laboratory, Detail Oriented, Documentation, English Language, External Audit, FDA Requirements, File Maintenance, Government, ISO (International Organization for Standardization), Insurance Regulations, Internal Audit, Leading Edge Technology, Manufacturing, Medical Equipment, Medical Products, Medical Records, Microsoft Excel, Microsoft Word, Multitasking, Process Validation, Product Documentation, Product Support, Quality Assurance, Quality Management, Quality Metrics, Regulations, Regulatory Requirements, Regulatory Submissions, Research & Development (R&D), Root Cause Analysis, Support Documentation, Validation Documentation, Validation Plan
Job available - immediate employment - Regulatory Affairs Specialist - Whip Mix - Whip Mix
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Job Description
Regulatory Affairs Specialist
Louisville, KY, United States of America
$70,000.00 - $80,000.00
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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
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