Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
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!
The Staff Regulatory Affairs position for Beckman Diagnostics is a high-level strategist, individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for new product development pre-market activities and managing complex issues that may have significant impact on the business.
This position is in the Hematology and Urinalysis business unit based in Miami, part of the Regulatory Affairs team, reporting to the Director of Regulatory Affairs. The role will be hybrid in Miami, FL (Relocation eligible) or may work fully remote (CST/EST time zones).
At Beckman Coulter Diagnostics 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 fully remote or hybrid work arrangement in which you can work part of the time at the Company location identified above and part of the time remotely from your home. Additional information about these arrangements will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.
This individual is accountable for leading global regulatory initiatives, working with third parties as appropriate. They will build consensus while championing global regulatory initiatives for projects and drive pre-market regulatory initiatives to ensure the development and implementation of sophisticated and aggressive regulatory strategies to give Beckman Coulter a driven competitive edge.
If you thrive in a fast-paced role and want to contribute to a world-class Regulatory Affairs organization—read on!
In this role, you will have the opportunity to:
The essential requirements of the job include:
It would be a plus if you also possess previous experience in:
At Danaher, we work to create and sustain an inclusive culture in which diversity within our workforce creates a competitive advantage in the markets we serve. By building and maintaining a culture rooted in inclusive values, we maximize the unique perspectives and fresh ideas available to drive our innovation, fuel our growth, and ensure our technologies and products serve a global customer base. A diverse and inclusive workforce strengthens Danaher and ensures the best team continues to win. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.
We are on a journey as an organization to increase the diversity of our associate population globally and to foster an environment where each person feels that they belong at Danaher.
At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
0 Regulatory Affairs Specialist jobs found in Miami, FL area