Staff Clinical Compliance Auditor

Bring more to life.

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

Within Danaher the work our diagnostic businesses do saves lives-and 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.

We're accelerating the development of cutting-edge diagnostics to solve some of the world's most pressing health challenges. Across our diagnostics operating companies we are driving innovation through partnerships with top academic institutions and leading players in biopharma and translational research. We're bringing the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances. Together, we're expanding access to precision diagnostics for millions of people worldwide - and we're using our unmatched global scale and proven playbook to make it happen, from hospital labs to mobile clinics. By helping providers, patients, and families get faster, more precise diagnostic results, we're improving treatment options and saving lives. Learn about the Danaher Business System which makes everything possible.

This position is part of the Danaher Diagnostics organization and is a remote role . At Danaher Diagnostics, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

The Staff Clinical Compliance Auditor (Global Focus - Remote) for Danaher Diagnostics is responsible for clinical quality and compliance. This includes study audit and inspection management activities across the Clinical Center of Excellence (CCOE).

You will be a part of the Clinical Compliance team and report to the Sr. Director of Global Clinical Compliance responsible for clinical quality and scientific writing to support new product research across four diagnostic operating companies within Danaher Diagnostics. If you thrive in a fast-paced, high impact role and want to work to build a world-class audit-ready Clinical organization-read on.

In this role, you will have the opportunity to :

Plan and execute internal audits of clinical trials, sites, vendors, and systems, and support external audits or regulatory inspections.

Lead a comprehensive schedule of audits to ensure Bioresearch Monitoring (BIMO) inspection and notified body (NB) audit readiness.

Lead the investigation of clinical quality issues, deviations, and non-conformances, managing the CAPA process to ensure effective resolution.

Provide expert guidance and training to clinical study teams and other relevant staff on compliance requirements, best practices, and the clinical QMS.

Monitor changes in relevant regulations and guidelines, assessing their impact on clinical operations and updating internal procedures accordingly.

The essential requirements of the job include

Bachelor's degree with 6+ years clinical quality experience within diagnostics or medical device industry, or Master's or Doctoral degree with 4 years of the same experience.

4 years of clinical quality auditing experience or a combination of clinical project auditing and clinical study experience.

In depth understanding of ISO 14155, 13485, 14971, 20916, in vitro diagnostic regulation (IVDR), medical device regulation (MDR), and pertinent sections of 21 CFR.

Highly motivated to work in a fast-paced environment with effective use of prioritization, organization, problem-solving and time management skills.

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

Certified auditor (e.g., ASQ CQA or ASQ CBA, GCP)

The technology and assays related to in vitro Diagnostic (IVD) across one or more of the following areas : chemistry, immunoassay, hematology, microbiology, or flow cytometry.

Danaher Diagnostics, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com .

Within Danaher Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working within Danaher Diagnostics can provide.

The annual salary range OR the hourly range for this role is $115K-$135K. 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 range may be modified in the future.

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.

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.

The U.S. EEO posters are available here (http : / / www.eeoc.gov / sites / default / files / 2023-06 / 22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .

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 .