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Within Danaher the work our diagnostic businesses do saves lives-and we're all united by a shared commitment to innovate for tangible impact.
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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.
The Assistant General Counsel provides strategic legal guidance to support the development, authorization, marketing, and lifecycle management of FDA-regulated medical device products, including in vitro diagnostics. This role partners closely with R&D, Quality, Clinical, Regulatory Affairs, Manufacturing, and Commercial teams to mitigate regulatory risk, lead compliance initiatives, and ensure adherence to U.S. and global device regulatory requirements.
This position reports to the Vice President and Regulatory Compliance Counsel, Diagnostics Platform and is part of the Danaher Diagnostics legal team. The position will be fully US remote.
In this role, you will have the opportunity to:

• Support operating companies' Quality Assurance and Regulatory Affairs teams by providing legal regulatory counsel on product issues, such as pre-market and post-market strategies and events
• Partner with R&D, Quality, Regulatory, and Operations teams to ensure regulatory compliance across the product lifecycle
• Support commercial Sales and Marketing teams by reviewing and advising on promotional materials and product launch strategies
• Monitor evolving FDA and global device regulations and advise leadership on potential regulatory and business implications
• Provide support for post-market activities, such as adverse event reporting, field actions, product marketing, inspections and audits

The essential requirements of the job include:

• J.D. from an accredited law school; admission to practice in relevant jurisdiction.
• Extensive experience advising on FDA medical device regulations, including product development, Quality System Regulation, product promotion, and enforcement matters
• Strong background in GMP/GDP investigations, FDA pre-market and post-market interactions, IVD and RUO marketing strategies
• Expertise in product promotional communications regulations and compliance, including on and off-label communications, product labeling, and promotional materials
• Excellent analytical and communication skills

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel - approximately 10-15%

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

• 8+ years supporting medical device manufacturers
• Knowledge of global medical device product regulatory frameworks and industry standards (e.g., ISO 13485, 14971)

Within Danaher Diagnostics, we offer 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 Danaher Benefits Info.
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 for this role is 250,000 - $275,000. 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 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.
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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.
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