at Danaher Corporation in Richmond, Illinois, United States
Job Description
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.
This position is part of the RAQC, Quality Assurance and Regulatory Compliance family, located in Richmond – IL and will be a hybrid position. At Leica Biosystems, our vision is to advance cancer diagnostics and improve lives.
You will be a part of the Regulatory Compliance and report to the Director QARC 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.
The Regulatory Compliance Specialist for Leica Biosystems is responsible for:
+ Prepares, reviews, and approves regulatory documentation for submission, including but not limited to Technical Files and DoCs to regulatory agencies or to commercial partners and provide advisement on the submission strategy.
+ Support new product development, design change and sustaining projects through the review and approval of design files connected to regulatory compliance.
+ Control new and change legislations related to Regulatory Affairs activities, actively participating on 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.
+ Act as Subject Matter Expert (SME) in site audits (i.e. MDSAP, GMP, MAPSS, etc.).
+ Investigate pathways to market and requirements to sustain regulatory compliance.
In this role, you will have the opportunity to:
+ Work with cross functional teams to bring IVD (In-Vitro Diagnostic), Research (RUO) and Laboratorial products to market and ensure ongoing compliance while continuing to develop regulatory affairs skills. This role will support Regulatory Affairs efforts requiring cross-site partnership and execution.
+ This role will support product registrations, listings, and renewals globally with support of Leica partners, and direct in US, Canada and EU. This role will support RA efforts requiring cross-site partnership and execution for new product and change management.
+ Develop strong problem solving and decision-making skills.
+ The Specialist will have the opportunity to learn the Danaher Business Systems (DBS) to improve quality, processes, and innovation by applying tools and continuous improvement mind-set.
The essential requirements of the job include:
+ 2-5 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
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At Leica Biosystems we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Biosystems can provide.
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.
At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. 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 (https://www.dol.gov/agencies/ofccp/posters) .
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.
