Leica Biosystems' mission of "Advancing Cancer Diagnostics, Improving Lives" is at the heart of our corporate culture. We're a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you're helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.

Leica Biosystems is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.

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 is part of the Regulatory Compliance team located in Richmond, Illinois and will be onsite. At Leica Biosystems, our vision is to advance cancer diagnostics and improve lives.

You will be a part of the Quality Assurance and Regulatory Compliance team and report to the Director, Quality Assurance and Regulatory Compliance (Management Representative), responsible for ensuring the company complies with regulatory requirements and maintains a robust and solid QMS. If you thrive in a multifunctional, fast paced and supporting role and want to work to build a world-class Regulatory Compliance organization, read on.

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 3 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.
  

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.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

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Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit

www.danaher.com
.

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. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.