Becton, Dickinson and Company

Sustaining & Compliance Projects Senior Manager, Regulatory Affairs

Becton, Dickinson and Company • $149K — $239K *
Sparks Glencoe, MD 21152In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
2 months ago
Job Overview by Ladders

Qualifications

  • B.S. degree or higher in a technical discipline (biology, microbiology, molecular biology, bioengineering)
  • 7+ years of experience in Quality Assurance, Regulatory Affairs or related fields
  • 5+ years of management experience with teams of 4 or more
  • 5+ years in project management, preferably with regulatory affairs projects
  • Strong experience in technical and procedure/policy writing
  • Knowledge of clinical diagnostics and ADx products is preferred

Responsibilities

  • Align regulatory strategies with business objectives by working closely with RA LT members
  • Lead a team of regulatory project managers on sustaining and compliance projects
  • Monitor worldwide regulations and communicate risks and mitigation strategies
  • Assess the impact of compliance and sustaining projects on Quality Management Systems (QMS)
  • Oversee regulatory submissions as needed
  • Represent Regulatory for Field Safety Corrective Actions
  • Engage in external activities to benefit Waters Advanced Diagnostics including trade associations and standards organizations
  • Allocate resources based on business priorities while managing team development

Benefits

  • Opportunity to lead high-impact regulatory projects
  • Access to professional development and management training
  • Collaboration with cross-functional teams and external stakeholders
  • Engagement with global regulatory standards and best practices
  • Comprehensive benefits package supporting employee well-being
Full Job Description
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.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
  • 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.


Education and Experience:
  • 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.


Knowledge and Skills:
  • 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.


Primary Work Location
USA MD - Sparks - 7 Loveton Circle

Salary Range Information
$149,600.00 - $239,400.00 USD Annual

About Becton, Dickinson and Company

BD is a global technology company that provides diagnostics and technologies for frontliners. Through their solutions and services, they assist scientists in detecting diseases and advanced researchers' on developing diagnoses and therapeutics. BD was established in 1897 by Farleigh Dickinson and Maxwell Becton in East Rutherford, New Jersey.

Becton, Dickinson and Company Careers

Join the innovative world of Becton, Dickinson and Company (BD), a global medical technology company that is actively seeking driven, dedicated professionals to join our team. At BD, we are committed to advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. This commitment provides the foundation for a workplace where you can engage in meaningful work and where job opportunities abound.

Work You’ll Do

At BD, you will be part of a culture that values diversity, leadership, and innovation. Our team members are empowered to lead and inspire from day one. Join us and contribute to our mission of advancing the world of health through your professional skills and personal passion.

Transform Your Career

BD offers a unique position in the marketplace that combines industry expertise, leadership in medical innovation, and a collaborative culture to help you grow your career. Whether you are looking for an entry-level position or a more senior role, we provide the tools and support for your professional growth through comprehensive training and development programs.

Innovative Work Environment

Our team at BD is composed of more than 65,000 associates across the globe. These dedicated professionals work at the intersection of technology and healthcare, where they drive innovation and ensure that we stay ahead in a rapidly evolving industry. By joining BD, you will work alongside some of the brightest minds in the industry.

Internship and Employment Opportunities

Start your career with BD through our internship programs or dive straight into a full-time position. We offer a range of opportunities that allow you to explore different areas of our business and find a path that aligns with your career goals. Our hiring process is designed to be transparent and engaging, ensuring that all candidates—whether submitting a resume for an internship or a senior position—feel valued and informed.

Benefits and Culture

BD is proud to offer competitive benefits that support the health, well-being, and financial security of our employees and their families. From comprehensive health insurance to employee wellness programs and flexible working arrangements, we prioritize the well-being of our team members. Our inclusive culture encourages networking, continuous learning, and the sharing of ideas in a diverse and welcoming environment.

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Explore the job opportunities at BD and discover how your expertise can help shape the future of healthcare. Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players.

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At Becton, Dickinson and Company, we are more than just a company; we are a community that is dedicated to making a difference in the lives of people all around the world.
Learn more about Becton, Dickinson and Company
Size
75,000 employees
Market Cap
$72 billion
Industry
Healthcare
Net Income
$1.6 billion
Founded
1897
5 Year Trend
+9.3%
Revenue
$18.2 billion
NASDAQ
BDX
* Ladders Estimates

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