Director Regulatory Affairs, Hematology, Urinalysis, Clinical Decision Support – Danaher

Job Description

Wondering what’s within Danaher? 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 Director of Regulatory Affairs, Hematology/Urinalysis/Clinical Decision Support leads the 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 interacting 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 groundbreaking 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.

The scope of this role encompasses supporting Hematology, Urinalysis, and Clinical Decision Support Business units. 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, continuing for the 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 prepare to navigate such ambitions in collaboration with clinical affairs leaders.
• Own execution of sound regulatory strategy for the business unit’s medical devices, IVDD, IVDR, and devices involving the 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.
• Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management; manages matrices effectively.
• Utilize Danaher Business System (DBS) tools to drive compliance and effective processes; develop regulatory metrics and scorecards and institute data-based process improvements that will align with corporate and business unit goals.
• Develop resourcing strategies, and allocates budgets, staff, tools, and specialized support necessary for efficient operations.

The essential requirements of the job include:
• Bachelor’s Degree in Regulatory, Engineering, or Quality assurance and 20+ years of experience, or Master’s/Doctoral degree and 18+ years of experience in a regulated medical device industry working with cross-functional product development teams. An advanced scientific degree is strongly preferred.
• 6+ years of management experience including proven ability to build and sustain a vision for team, and track record of developing talent agility and organizational capabilities.
• Subject Matter Expert in regulatory affairs for medical devices, preferably with in vitro diagnostics or digital health.
• Demonstrated experience with regulations, standards, and guidelines governing medical devices, preferably including in vitro diagnostics and digital healthcare.
• Experience in the development, labeling, registration, and commercialization of medical devices and diagnostic products.
• Mastery in the development of effective strategies for positive impact on global-based teams.
• Established relationships with regulatory agencies including FDA.

It would be a plus if you also possess experience in:
• Professional designations, training, certificates in quality, regulatory affairs, and software development (e.g. RAC, CQE, Six Sigma, Lean Principles, JAVA, Agile, MS Apps)
• Critical thinker able to address complex situations and issues.
• Influential and a strong negotiator, with agility in managing changing conditions, leading through change effectively.
• Ability to adopt a systemic view of process improvement and advise on goal attainment.

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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.

The salary range for this role is $215-235K. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range.

This job is also eligible for bonus/incentive pay. We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

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 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.

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.