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

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

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