Regulatory Affairs Strategist, Project Management

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 Description The Regulatory Affairs Strategist , Project Management , is responsible for acting as a subject matter expert and project manager for various high-profile initiatives and business critical projects within BD Regulatory Affairs that may influence across multiple functions . T he RA Strategist will act as a Kaizen facilitator across RA teams and will use and guide teams through the Problem-Solving Process (PSP) . This role will be responsible for identifying opportunities for optimization across the RA team, and partner to implement best practices and business solutions across central RA teams, BU and Regional teams . This role requires the ability to manage to a high level of project complexity and be able to influence the organization accordingly to ensure project success . The role requires a significant understanding of the Regulatory function and its associated activities .

Job Responsibilities:

(Primary Duties, Roles, and/or Authorities) Proven track record of project management with a regulatory focus. Facilitat ion of global RA Kaizen events . Responsible for data analytics and reporting on metrics and key product indicators (KPIs) and activities acros s BDX RA. Lean manufacturing execution in BDX excellence principles - apply the problem sol ving methodology to drive the Central RA team . Help to lead process improvements and compliance projects applicable to the BD product portfolio. Manag e large - scale programs consisting of multiple active projects from project definition through program governance, monitoring and close out. This includes identifying and aligning resources on integration points. Provide guidance and support to strategic business partners to ensure best practices and project methodologies are followed. Adhere to BD established standards for project and program planning, execution and close out . Governance process owner (GPO) of BDX RA standard operating procedures, best practices, and ways of working . This includes working with various SMEs and business process owners throughout the organization to ensure content is accurate and complete .

Minimum Requirements:

Bachelor's degree in science, engineering, or technology discipline required. Minimum of 8 years of Regulatory and/or Quality experience including project management within a medical device industry or similar regulated industry , with preference for experience in both a Quality and Regulatory role .

Preferred Qualifications:

Master's degree in business, management, or technology related field preferred. P roject Management Professional (P MP ) or similar certification preferred . Regulatory Affairs Certification (RAC). Certifi cation in the Problem - Solving Process (PSP 101) and Kaizen initiatives . ​ ​

Knowledge and Skills:

Organization & Planning:

Organizes personal and organizational projects and tasks, for assigned projects, enlisting resources to efficiently meet project needs.

Problem Solving, Analytical Skills and Professional Judgement:

Uses a combination of logic, analysis, and experience to provide regulatory assessments and recommendations.

Decision Quality:

Developing ability to assess risk and clarify ambiguous situations to make good recommendations.

Communication Skills:

Able to present problems and recommendations to senior management effectively...

Action Oriented:

Demonstrates a significant bias for action to execute key objectives.

Courage & Independence:

Able to escalate issues as needed and make key recommendations within area of focus.

Composure:

Responds constructively in stressful situations and escalate issues as needed.

Flexibility:

Adapts plans to changing priorities.

Process Effectiveness:

Works to identify ways to simplify and implement complex processes and able to reach out for help where needed. Dealing with

Ambiguity:

Able to assess risk, competing needs and priorities and develop solutions.

Physical Demands:

(if applicable) When work is performed in an office environment the position requires the ability to operate standard office equipment and keyboards. Must have the ability to stand, walk and sit; talk or hear, both in person and by telephone; use hands to finger, handle or feel objects or controls; reach with hands and arms. Ability to travel US and OUS travel ~25% At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against

COVID-19.

In some locations, testing for

COVID-19

may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. At BD, we are committed to supporting our associates' well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role: Annual Bonus Potential Discretionary LTI Bonus Health and Well-being Benefits Medical coverage Health Savings Accounts Flexible Spending Accounts Dental coverage Vision coverage Hospital Care Insurance Critical Illness Insurance Accidental Injury Insurance Life and AD&D insurance Short-term disability coverage Long-term disability insurance Long-term care with life insurance Other Well-being Resources Anxiety management program Wellness incentives Sleep improvement program Diabetes management program Virtual physical therapy Emotional/mental health support programs Weight management programs Gastrointestinal health program Substance use management program Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit Retirement and Financial Well-being BD 401(k) Plan BD Deferred Compensation and Restoration Plan 529 College Savings Plan Financial counseling Baxter Credit Union (BCU) Daily Pay College financial aid and application guidance Life Balance Programs Paid time off (PTO), including all required State leaves Educational assistance/tuition reimbursement MetLife Legal Plan Group auto and home insurance Pet insurance Commuter benefits Discounts on products and services Academic Achievement Scholarship Service Recognition Awards Employer matching donation Workplace accommodations Other Life Balance Programs Adoption assistance Backup day care and eldercare Support for neurodivergent adults, children, and caregivers Caregiving assistance for elderly and special needs individuals Employee Assistance Program (EAP) Paid Parental Leave Support for fertility, birthing, postpartum, and age-related hormonal changes Leave Programs Bereavement leaves Military leave Personal leave Family and Medical Leave (FML) Jury and Witness Duty Leave Why Join Us? 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. To learn more about BD visit https://bd.com/careers . Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Required Skills Optional Skills . Primary Work Location USA NJ - Franklin Lakes Additional Locations Work Shift At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under " Our Commitment to You ." Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed. Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role. Salary Range Information $137,500.00 - $220,100.00 USD Annual