Danaher Corporation Staff Regulatory Affairs, Medical Device- Remote in Dallas, Texas
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, New Product Development for Beckman Diagnostics is a high-level strategist, individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for 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 Senior Manager of Regulatory Affairs. The role will be fully remote (CST/EST time zones preferred).
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:
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.
Collaborate with Program Managers and technical staff, cross functional project teams to provide regulatory strategy for devices and resolve action items and deliverables needed for market clearance.
Apply AI and ML in the development of next generation technology.
Establish the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval for new products and/or changes to existing products.
Create and manage Technical Files in compliance with IVDR and work with international colleagues on establishing design dossiers for their intended market for new product development and design changes.
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.
Prepare the vital documentation and secure approvals and respond to regulatory agency inquiries.
Apply and/or write complete the following certificates: FDA Certificates to Government and Export Certificates, Certificates of Free Sales, and Declaration of Conformity.
Lead legalization, Apostille, and notarization process.
Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements and provide regulatory oversight in support of design changes.
Advise business teams to consider the impact of current or emerging regulatory issues, works with colleagues globally to facilitate.
Ensure company practices are consistent with the corporate regulatory risk posture.
Assure sound post-market product regulatory strategies including minimizing the risk of negative post-market submissions needed for design changes, such as agency review delays.
The essential requirements of the job include:
Bachelor's Degree with 9+ years of experience in regulatory affairs, or a Master’s degree with 7+ Years of experience in regulatory affairs, or Doctorate with 5+ years of experience in regulatory affairs. Experience in IVD regulatory affairs is highly preferred.
Subject matter expertise in registration and commercialization of medical devices, including 510(k) to the FDA
Demonstrated experience developing effective pre-market regulatory strategies
Demonstrated knowledge and understanding of regulations and guidelines governing in-vitro diagnostics
Experience with medical device development process, design changes and design controls; establishing and implementing premarket regulatory strategy; writing and submitting premarket submissions to regulatory agencies; preparing submissions for FDA establishment registrations, Canadian site license renewals, US State licenses and USDA licenses.
Experience communicating with regulatory agencies including FDA, Health Canada and EU regulatory agencies.
FDA audits in multiple roles (regulatory representative, back-room lead, scribe, etc.) and capability to pull data and provide supporting documentation in a timely manner when faced with limited time and resources.
Works highly autonomously/independently, is pragmatic with strong problem-solving skills.
Experience working with cross-functional product development teams to ensure regulatory compliance.
It would be a plus if you also possess previous experience in:
Knowledge of EU IVDR regulations
International experience with products in China or Europe
At Beckman Coulter 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 for Beckman Coulter Diagnostics 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 firstname.lastname@example.org to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.