The essential requirements of the job include: - Bachelor’s degree in Degree in Science, Engineering or Regulatory Affairs and 14+ years of experience, or Master’s/Doctoral degree and 12+ years of experience in a regulated medical device industry working with cross-functional product development teams. Experience will be considered in lieu of specific degrees.
- 4+ years supervisory and management experience.
- Success negotiating complex premarket and post market regulatory strategies with FDA, NMPA and other regulatory agencies.
- Experience authoring 510(k)s and product life cycle regulations, including change controls, design controls, risk management, along with knowledge of clinical study requirements and verification and validation activities.
It would be a plus if you also possess: - In Vitro Diagnostic experience
- Professional designations are not required but training and relevant certifications would be a plus (e.g. RAC, CLIA, ASQ Certified Biomedical Auditor or Manager of Quality/Organizational Excellence)
Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates’ and their families’ 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. We believe you’ll like what you see. Beckman Coulter is a Danaher Operating Company. As a $20B company with 60,000 associates, ranked #162 on the Fortune 500 and, during the past 25 years, DHR stock has outperformed the S&P 500 Index by more than 5,000 percent. The strength of our results is a testament to our teams and the power of the Danaher Business System. Our Purpose: “Helping Realize Life’s Potential” is what makes us excited to come to work each day! At Danaher, we’re driven by a sense of wonder for what we can create—and what we can become. Accelerate your career while driving innovation that improves lives. Work hard and take risks, with guidance from committed leaders, powerful DBS tools, and the support of a global organization. If you’d like to learn more, read stories from our associates on our Careers Blog or reach out to one of our recruiters. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here. Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 202-419-7762 or email applyassistance@danaher.com to request accommodation. |
