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

Principal Specialist, Regulatory & Quality Management Systems {Cary, IL} (Heads up req) (BH-109535) Location: Cary, United States Sector: Health & Safety Job Title: Regulatory & Quality Systems Specialist Contract Duration: 12 Months (with potential for extension) Location: Cary, IL (On site) 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. Key Responsibilities 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. Required Qualifications 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. #J-18808-Ljbffr The Matlen Silver Group, Inc.