Sustaining & Compliance Projects Senior Manager, Regulatory Affairs

Usa Md - Sparkssenior

OtherRegulatory Affairs

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Quick Summary

Key Responsibilities

(Primary Duties, Roles, and/or Authorities) Works closely with RA LT members to ensure alignment of regulatory strategies with business objectives.

Technical Tools

OtherRegulatory Affairs

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

The Sustaining & Compliance Projects Senior Manager will be responsible for ensuring continued regulatory compliance of the portfolio as worldwide regulations and standards, as well as internal policies, procedures, and business goals, evolve. The position will lead a team of regulatory project managers and be responsible for ensuring all projects remain on schedule and deliverables are met. The role will routinely work with cross functional teams and contractors to achieve goals. Critical thinking, strategic agility and dealing with ambiguity are key skill sets for this role.

Responsibilities

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B.S. degree or higher required, strongly preferred in a technical discipline (biology, microbiology, molecular biology, bioengineering)
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Minimum of 7 years of cumulative work experience in Quality Assurance, Regulatory Affairs or other closely related field.
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Minimum of 5 years of management experience leading teams of 4+
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Minimum of 5 years of experience with project management. Experience managing RA related projects preferred.
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Experience in leading cross functionally, prioritizing, and driving tasks to completion.
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Experience in technical and procedure/policy writing.
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Knowledge of clinical diagnostics preferred.
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Knowledge of ADx (formerly BD Diagnostic Systems) products preferred.

Ability to think strategically, to detect the essence of complex or ambiguous issues, and to put these in the context of larger, systemic issues.
Strong business orientation - ability to communicate and interact effectively with senior business leaders.
Strong background in project management with demonstrated success at bring projects to completion on time.
Ability to inspire, motivate, and build the confidence of teams to reach goals, steadfastly pushing self and others to achieve results.
Demonstrate leadership courage through openness to diverse views, candor in assessing and articulating difficult positions, and willingness to make changes when needed.
Demonstrate success in supporting both growth and product support projects, including complex projects involving ambiguity, in a rapidly changing regulatory environment
Ability to attract, recruit, mentor, and retain high-caliber professionals.

What We Offer

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To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.