Sustaining & Compliance Projects Senior Manager, Regulatory Affairs

Becton Dickinson Medical Devices•Sparks, NV

2d•Onsite

About The Position

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. We are the people who give possibilities purpose 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. Job Summary: 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.

Requirements

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

Responsibilities

Works closely with RA LT members to ensure alignment of regulatory strategies with business objectives.
Provides leadership to a team of regulatory project managers as they run various sustaining and compliance projects.
Stays abreast of worldwide regulations and standards and communicates potential risks and mitigation strategies to stakeholders.
Possesses extensive knowledge of Quality Management System (QMS) and assesses impacts of compliance and sustaining projects.
Assesses need for regulatory submission and oversees submissions where necessary.
Represents Regulatory for all Field Safety Corrective Actions and Situation Analyses.
Represents company interests in external activities benefiting Waters Advanced Diagnostics (ADx), including trade associations, professional organizations, and standards development organizations.
Manages and develops regulatory affairs project managers and specialists carrying out compliance/sustaining activities.
Assesses resource requirements based on business priorities and allocates personnel as required to meet these objectives.
Aligns right capabilities to challenging tasks.
Clearly defines and articulates performance goals, with assigned accountabilities, clear decision authority, and an intense focus on alignment.
Develops direct reports with regard to required competencies, including, but not limited to, regulatory knowledge and ability to apply this knowledge, effectiveness in team and one-to-one interactions, and verbal and written communications.