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# Principal Specialist, Regulatory & Quality Management Systems {Cary, IL} (Heads up req)

- **Company:** Matlen Silver
- **Location:** Cary, IL, United States
- **Contract:** Temporary to permanent
- **Skills:** Data Analysis, Microsoft Office, Mdsap
- **Published:** June 11, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=a1d3bd662290fdb1

## About the Role

Do you have experience in Vendor compliance audits?, * Bachelor's degree required, preferably in Engineering, Life Sciences, Regulatory Affairs, or a related field

 * Strong knowledge of FDA, EU MDR, MDSAP, and other international medical device regulations
 * Direct experience with U.S. 510(k) submissions and EU Class II device compliance
 * In-depth understanding of Quality Systems and relevant standards (e.g., ISO 13485)
 * Proven audit experience (internal, supplier, and regulatory)
 * Excellent project management, analytical, and decision-making skills
 * Strong written and verbal communication and interpersonal skills
 * Ability to manage multiple priorities in a fast-paced environment
 * Experience in technical writing and procedure development
 * Proficiency with Microsoft Office and relevant quality/regulatory software
 * Ability to travel occasionally, as required

## Description

Position Overview: We are seeking a highly skilled Regulatory & Quality Systems Specialist to support regulatory compliance and quality initiatives for medical devices, both in the U.S. and internationally. The ideal candidate will have in-depth knowledge of U.S. FDA regulations, EU MDR, and MDSAP, with hands-on experience in 510(k) submissions and EU Class II devices. This is a contract role based on-site in Cary, IL, offering an exciting opportunity to contribute to high-impact regulatory and quality operations., * Ensure compliance with U.S. and international medical device regulations, including MDSAP

 * Provide regulatory support for 510(k) submissions and EU Class II device registrations
 * Maintain and improve Quality Management Systems (QMS) across key areas, including:
 * Measurement, Analysis, and Improvement
 * Adverse Event and Advisory Reporting
 * Purchasing and Supplier Controls
 * Design & Development
 * Production and Service Controls
 * Lead or support internal and external audits
 * Develop and maintain technical documentation, including procedures and SOPs
 * Collaborate cross-functionally with R&D, Operations, and Regulatory Affairs teams
 * Monitor and assess compliance risks, recommending and implementing corrective actions
 * Analyze data to identify trends and define actionable improvements
 * Communicate effectively with stakeholders across all levels of the organization
 * Support project planning and execution across multiple concurrent tasks
 * Act with a customer- and stakeholder-focused mindset


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