Danaher Corporation Senior Manager Regulatory Affairs, New Product Development in Brea, California
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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, New Product Development leads strategic regulatory direction for multiple new product programs and innovative solutions for whole blood and urine diagnostic tests.
Reporting to the Vice President, Quality and Regulatory Affairs, this position has the primary responsibility of leading next generation digital technologies and directing a team through the regulatory submission process, preparing the registrations, and interaction with the FDA and notified bodies. In this leadership role, you will help craft an innovative diagnostics regulatory strategy for new diagnostic (Dx) products that use machine learning and AI technology to improve clinical outcomes. This role works closely with clinical affairs to drive novel regulatory submissions for claims expansions on existing products.
Beckman Coulter is seeking a passionate, ambitious leader to join our team in this ground breaking digital healthcare transformation journey, and likewise be driven by our strong sense of purpose to improve patient outcomes. We are on a quest for an individual who thrives working in a sophisticated fast-paced environment with a strong sense of urgency and a proven track record of flexibility and adaptability.
This position is remote with up to 25% travel in the future as needed.
In this role, you will have the opportunity to:
Accountability for regulatory timelines and management of regulatory submissions and compliance for our traditional and digital Dx solutions. Provide regulatory oversight, including leading all communications and submissions with regulatory agencies, continues for entire product development life cycle, including post-market surveillance.
Future regulatory submissions may include expansion of claims to existing products where regulatory submissions as digital solutions are developed to meet emerging clinical needs, and be prepared to navigate such ambitions in collaboration with clinical affairs leaders.
Own execution of sound regulatory strategy for the business unit’s medical devices involving use of Artificial Intelligence and Machine Learning to achieve clearances/approvals in alignment with business priorities.
Cultivate and maintain a strong grasp of regulatory guidance and trends, ensuring information is disseminated across the business unit for effective decision making.
The essential requirements of the job include:
Bachelor’s 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.
4+ years management and In Vitro Diagnostics experience.
Subject Matter Expert in pre- and post-market medical device regulations, requirements, and submissions, De Novo submissions, PMA, 510(k), and 21CFR820.30. Familiarity with ISO 62304 and IEC/ISO 62304 medical device software life cycle process desired.
It would be a plus if you also possess experience in:
Advanced degree in biological, biomedical, or data science/software
Experience working in the acute care healthcare space
Awareness of global digital health regulations and requirements
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 fully 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 firstname.lastname@example.org to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.