Job Description

Leica Biosystems Specialist, Regulatory Compliance

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Leica Biosystems, one of Danaher's 15+ operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact innovating at the speed of life.

At Leica Biosystems, we're not just shaping the future of cancer diagnostics we're transforming lives. Our mission of "Advancing Cancer Diagnostics, Improving Lives" is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you're not just taking a job; you're becoming part of a passionate team that knows every moment matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you'll be inspired each day to stretch, grow, and make an impact.

The Specialist, Regulatory Compliance for Leica Biosystems is responsible for working with cross-functional teams to bring IVD (In-Vitro Diagnostic), Research (RUO) and Laboratorial 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) and is part of the Regulatory Compliance team located in Richmond, Illinois and will be an on-site role.

In this role, you will have the opportunity to:

• Prepare, review and approve regulatory documentation for submission, including but not limited to Technical Files and DoCs, to regulatory agencies or to commercial partners, and advise on the submission strategy.
• Support new product development, design change, and Sustain projects by reviewing and approving design files connected to regulatory compliance, using strong problem solving and decision-making skills.
• Control new and change legislations related to Regulatory Affairs activities, actively participating in committees and meetings to discuss new guidance. Identify relevant guidance documents, or consensus standards and provide interpretive assistance.
• Review and approve Advertising and Promotional Materials (MAPSS) to ensure compliance with regulations in country/countries where materials are distributed and act as Subject Matter Expert (SME) in site audits (i.e. MDSAP, GMP, MAPSS, etc.).
• Support product registrations, listings, and renewals globally with the support of Leica partners, and directly in US, Canada, and EU, requiring cross-site partnership and execution for new products and change management.

The essential requirements of the job include:

• Bachelor's degree or a minimum of three years' equivalent experience
• Minimum of two 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.
• Experience with ISO 13485:2016, IVD/MDR Regulations, FDA GMP and domestic/international Medical Device Regulations.

It would be a plus if you also possess previous experience in:

• Histopathology / Pathology field
• Chemicals
• Using Danaher Business Systems (DBS) tools to improve quality, processes, and innovation by applying tools and continuous improvement mind-set

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel - must be able to travel up to 10% of the time, (domestic and international).
• Overnight travel may be required.

The annual salary range for this role is between $80,000 - $90,000. This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.

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