Senior Specialist, Regulatory Compliance

Leica Microsystems • Richmond, IL

96d • $110,000 - $120,000

About The Position

The Senior Specialist, Regulatory Compliance for Leica Biosystems is responsible for working with cross-functional teams to bring IVD (In-Vitro Diagnostic), Research (RUO), and Laboratory products to market and support activities related to Quality Management System (QMS) to ensure ongoing compliance while continuing to develop regulatory affairs skills. This position reports to the Director, Quality Assurance and Regulatory Compliance (Management Representative), it is part of the Regulatory Compliance team located in Richmond, Illinois, and will be on-site.

Requirements

• Bachelor's degree in science, medical, or technical field, or equivalent experience.
• Minimum of five years' experience within medical device/IVD.
• FDA (Class I & II) and Health Canada regulatory knowledge including registration maintenance, device listings, regulatory requirements, and North America IVD regulatory intelligence.
• EU (MDR/IVDR) regulatory knowledge including registration maintenance, device listing, regulatory requirements, Importer and Authorized Representative actions.
• Proven experience executing internal and external audits in alignment with applicable medical device standards.

Nice To Haves

• Previous experience in Histopathology / Pathology field.
• Experience using lean manufacturing tools including Danaher Business Systems (DBS) tools to improve quality, processes, and innovation.
• Certified Quality Auditor (CQA), or equivalent certifications.

Responsibilities

• Prepare, review, and approve regulatory documentation for global registrations, with support of Leica global partners, and work directly with the Regulatory Authorities in registrations for the US, Canada, and EU markets.
• Drive new product development, design change, and sustaining projects by reviewing and approving design files connected to regulatory compliance.
• Collaborate in cross-functional and cross-site partnership in the execution of the projects.
• Lead internal and external audits, including interacting directly with auditors during site inspections, responding to audit findings by proposing and implementing necessary corrective actions.
• Collaborate with team members to adapt regulatory activities within the Quality System, simplifying and aligning QMS requirements with ISO 13485, MDSAP, IVDR, and other relevant standards.
• Control department budget, working closely with Finance Department to ensure accuracy with department goals.

Benefits

• Comprehensive package of benefits including paid time off.
• Medical/dental/vision insurance.
• 401(k) to eligible employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree