Principal Specialist, Regulatory & Quality Management Systems {Cary, IL} (Heads up req)
Matlen Silver
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
Vacancy posted 3 days ago
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