Senior Specialist, Regulatory Compliance

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 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.

In this role you will have the opportunity to:

• 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 using strong problem-solving and decision-making skills to enable effective navigation of complex operational scenarios aligned with site requirements. 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 defining the best course of action for such adaptations.
• Control department budget working closely with Finance Department to ensure accuracy with department goals.

The essential requirements of the job include:

• Bachelors 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.

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

• Histopathology / Pathology field
• Chemicals
• Using lean manufacturing tools including Danaher Business Systems (DBS) tools to improve quality processes and innovation by applying tools and continuous improvement mind-set
• Certified Quality Auditor (CQA) or equivalent certifications

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 $110000 - $120000. 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 Companys 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.

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