Danaher Corporation Senior Manager, Regulatory Affairs - Remote in Carlsbad, California
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 Senior Manager, Regulatory Affairs for Beckman Coulter Diagnostics is responsible managing the Regulatory Affairs team for the Microbiology business supporting the mission of collaborating with Product Development and other functional groups to efficiently bring regulatory compliant new products to market.
This position is part of the Regulatory Affairs Department located in Sacramento, CA and will be hybrid, and there is also an option for the role to be fully Remote. Within Microbiology, our vision is to ensure that every patient has access to the right antibiotic at the right time.
You will be a part of the Quality, Regulatory, and Clinical Affairs (QRC) team and report to the Director of Quality, Regulatory, and Clinical Affairs responsible for leading and managing quality management/compliance, regulatory strategies, and clinical research. If you thrive in a dynamic leadership role and want to work to build a world-class regulatory organization—read on.
In this role, you will have the opportunity to:
Review, direct and manage regulatory strategies and execute to ensure ongoing innovation and adaptation to the changing needs of our customers, global regulatory agencies and authorities, and the business.
Liaise, negotiate, and orchestrate meetings and communications with FDA
Formulate regulatory strategy and tactics for all regulatory submissions
Ensures projects are resourced appropriately and that regulatory associates are qualified and trained. Meets business needs through effective collaboration across R&D programs located in multiple global regions, other businesses and across operating companies
Provide market segment leadership and subject matter expertise for the Regulatory Affairs sphere.
Speak to and demonstrate knowledge as it relates to regulatory affairs in the US, EU and other international markets
The essential requirements of the job include:
Bachelor’s Degree in a scientific or engineering field with 14+ years’ progressive experience working with regulatory requirements and agencies (FDA, IVDD and ISO 13485 required) Or Master’s/PhD with 12+ years’ experience
4 years’ supervisory experience managing people
Knowledge, understanding and experience with successful application of IVD microbiology development strategies and developing US regulatory submissions
Broad knowledge of Regulatory & Compliance Development for medical devices
Experience with pre-market regulatory activities (new product development) as well as post market activities (recalls, complaint handling, adverse event reporting)
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)
Master or Doctoral Degree in Science, Healthcare, or Regulatory Affairs
Managing a regulatory affairs team, including international regions
Leadership experience in managing both processes and resources
Danaher is committed to a diverse and inclusive culture where everyone feels they belong, and all voices are heard. 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.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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 require all US and Puerto Rico employees to be vaccinated against COVID–19 as a condition of employment, subject to reasonable accommodation as required by law.
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 email@example.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.