Regulatory Affairs Specialist (Richmond)

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Bring more to life.

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

At Leica Biosystems, one of Danahers 15+ operating companies, our work saves livesand were all united by a shared commitment to innovate for tangible impact.

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

At Leica Biosystems, were not just shaping the future of cancer diagnostics were 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, youre not just taking a job; youre becoming part of a passionate team that knows every moment matters when it comes to cancer. Youll 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, youll be inspired each day to stretch, grow, and make an impact.

Learn about the Danaher Business System which makes everything possible.

The Regulatory Affairs Specialist 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 onsite.

In this role, you will have the opportunity to :

Support product registrations, listings, and renewals globally with the support of Leica partners, and directly in US, Canada, and EU markets, requiring cross-functional and cross-site partnership and execution for new products and change management.

Support new product development, design change, and sustainment projects by reviewing and approving design files connected to regulatory compliance, using strong problem solving and decision-making skills.

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.

Control new and change legislations related to Regulatory Affairs activities, actively participating in committees and meetings to discuss new guidance including identifying relevant guidance documents, or consensus standards and providing interpretive assistance.

Review and approve Advertising and Promotional Materials (MAPSS) to ensure compliance with regulations in country / countries where materials are distributed, and explain complex information and respond to relevant questions raised during audits

The essential requirements of the job include :

Bachelors degree in science, medical, or technical field or equivalent experience.

Minimum of two years experience within medical device / IVD, across a variety of regulatory submissions, compliance initiatives, and cross-functional projects.

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

Demonstrated strong communication and collaboration skills across technical and non-technical teams

Using lean manufacturing tools including 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 is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting.

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 Companys sole discretion, consistent with the law.

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Join our winning team today. Together, well accelerate the real-life impact of tomorrows 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.

The U.S. EEO posters are available here .

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and / or to receive other benefits and privileges of employment, please contact : 1-202-419-7762 or applyassistance@danaher.com .