Danaher

Assistant General Counsel, Regulatory Compliance

Danaher • $250K — $275K *
US-AnywhereRemote in United States
Healthcare
8 - 10 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • J.D. from an accredited law school; admission to practice in relevant jurisdiction.
  • Extensive experience with FDA medical device regulations and product development.
  • Strong background in GMP/GDP investigations and FDA pre-market/post-market interactions.
  • Expertise in regulations for product promotional communications, labeling, and compliance.
  • Excellent analytical and communication skills.

Responsibilities

  • Support Quality Assurance and Regulatory Affairs teams by providing legal counsel on product issues.
  • Partner with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.
  • Review and advise on promotional materials and product launch strategies for Sales and Marketing teams.
  • Monitor and advise on evolving FDA and global device regulations.
  • Provide support for post-market activities, including adverse event reporting and inspections.

Benefits

  • Comprehensive health care programs including medical, dental, and vision insurance.
  • 401(k) plan for eligible employees.
  • Paid time off to promote work-life balance.
  • Remote work arrangement to accommodate flexibility.
  • Commitment to designing a sustainable workforce and enriching careers.
Full Job Description
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 . 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. #LI-VM1

About Danaher

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. More than 275,000 Beckman Coulter systems operate in both Diagnostics and Life Sciences laboratories on seven continents. For more than 75 years, our products have been making a difference in peoples' lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and delivering trusted solutions for research and discovery.

Danaher Careers

Joining Danaher means becoming part of a global team committed to driving growth, innovation, and leadership across various industries. At Danaher, we offer more than just job opportunities; we provide a platform for professional development and personal achievement.

Work You’ll Do

At Danaher, you will engage in work that propels global industries forward through innovation and leadership. Our team at Danaher is dedicated to enhancing the company's impact on science, technology, and healthcare. We believe in fostering a culture of diversity and inclusion, where every team member’s contribution is valued.

Explore Danaher’s Career Opportunities

Whether you are looking for a full-time position, an internship, or a leadership role, Danaher offers a range of employment opportunities to help you advance your career. Our hiring process is designed to identify and attract professionals who are not only skilled but are also passionate about making a difference.

Innovate and Grow with Us

Join a team where innovation is at the heart of everything we do. Danaher’s commitment to innovation drives our leadership in the market and our ability to offer unique solutions to our clients. Here, your skills in technology, problem-solving, and creativity will be honed through challenging projects and a collaborative work environment.

Benefits and Culture

Danaher is dedicated to providing a supportive work environment where careers flourish. Our benefits package is designed to support the health, well-being, and financial security of our employees and their families. From diversity training to professional development programs, we invest in every employee's growth and well-being.

Networking and Professional Development

At Danaher, networking and professional development are part of our DNA. We encourage our employees to connect with colleagues and leaders through various networking events, training sessions, and collaborative projects. This culture of growth and learning helps every team member build a rewarding career filled with exciting new challenges and opportunities.

Join Our Team

Ready to take the next step in your career? Explore the open positions on our Danaher Careers page. Tailor your resume, prepare for your interview, and join a team that’s dedicated to making a real impact. At Danaher, your career is just the beginning of a journey filled with leadership opportunities, innovative projects, and a chance to work with some of the brightest minds in the industry.

Stay Connected

Keep up to date with the latest from Danaher by subscribing to our job alert emails. Get insights into our company culture, read about our industry-leading innovations, and learn about new job openings tailored to your interests and skills.

Danaher: Where Careers Grow

At Danaher, we are not just creating job opportunities; we are building careers that make a difference. Join us in our mission to shape the future through innovation, leadership, and growth.
Learn more about Danaher
Size
78,000 employees
Market Cap
$189 billion
Industry
Business Services
Net Income
$3.6 billion
Founded
1969
5 Year Trend
+11.8%
Revenue
$22.2 billion
NASDAQ
DHR
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Danaher

More Healthcare Jobs

Find similar Assistant General Counsel, Regulatory Compliance jobs:

NationwideRemote