Senior Specialist, Regulatory Compliance

Senior 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 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 :

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

Travel, Motor Vehicle Record & Physical / Environment Requirements :

The annual salary range for this role is between $110,000 - $120,000. 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 Company's sole discretion, consistent with the law.