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Danaher Corporation Senior Analyst, Regulatory Affairs- Remote in Miami, Florida

Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.

At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

The Senior Analyst, Regulatory Affairs must operate autonomously and independently while also being adaptable to working within dynamic groups to drive collaborative and inclusive outcomes. The Senior Analyst Regulatory Affairs must be a high-level strategist, responsible for leveraging best practices and subject matter expertise, in supporting the Regulatory Affairs team for the Microbiology business. If you thrive in a fast-paced dynamic role and want to have a meaningful and impactful career with a world-class Regulatory Affairs organization—read on!

The Senior Analyst, Regulatory Affairs primary responsibilities include evaluation, coordination, preparation and implementation of post-market regulatory activities, executing existing regulatory initiatives, collaborating with third parties, including but not limited to, post market surveillance reporting, clinical & analytical performance evaluations, supporting international registrations, design change evaluations and promotional marketing reviews. Additionally, this position the mission of collaborating with Product Development and other functional groups to effectively bring regulatory compliant new products to market and sustaining existing.

This position is part of the Microbiology Regulatory Affairs Department and will be fully remote and reports to the Senior Manager of Regulatory Affairs. At Microbiology, our vision is to ensure that every patient has access to the right antibiotic at the right time.

In this role, you will have the opportunity to:

  • Network with a strong team of engineers, scientists and regulatory specialists dedicated to excellence and innovation.

  • Review, guide and facilitate regulatory strategies to ensure ongoing innovation and adaptation to the changing needs of our customers, global regulatory agencies and authorities, and the business.

  • Via international regulatory knowledge liaise, negotiate, and facilitate meetings, communications and audits with NGO’s and government agencies.

  • Author global pre-market submissions, including 510(k)s and PMA supplements to the U.S. FDA in alignment with pre-market and post-market strategies.

  • Prepare regulatory documentation for registering product globally, including but not limited to EU, CANADA, Latin America, Asia Pacific, METAM

  • Secure necessary country licenses (country approvals), certificates (e.g. CFGs, COE), and renewals (e.g. CE renewals) required to market company’s products in that geography.

  • Complete the following certificates: FDA Certificates to Government and Export Certificates, Certificates of Free Sales, and Declaration of Conformity.

  • Drive KPI's and global performance in terms of regulatory compliance and product market retention and expansion.

The essential requirements of the job include:

  • Bachelor’s Degree in a scientific or engineering field with 5+ years’ progressive experience working with regulatory requirements and agencies, or Master’s degree in field with 3+ years’ experience, or PhD in field with 0+ years’ experience

  • Conceptual and operational expertise and successful application of FDA, IVD/IVDR microbiology development strategies and developing US regulatory submissions

  • Experience with pre-market regulatory activities (new product development) as well as post market activities (recalls, complaint handling, adverse event reporting)

  • IVDR Technical File and Declaration of Conformity creation and update, consumable, and instrument labeling

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

  • Knowledge of microbiology regulations and guidance documents (FDA Class II Special Controls Guidance on AST, ISO 20776, CLSI M100)

  • Experience with hardware/software medical device registrations.

  • RAC certificate, ISO 13485

  • Proficient with Adobe Acrobat, Excel, and Word

At Beckman Coulter we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work portion of your time at the Company location identified above and a portion remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter can provide.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

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. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.