Probabilistic Risk Assessment Engineer Jobs in Batavia, NY

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 Regulatory Affairs Associate Director, Globalization is responsible for alignment and execution of worldwide regulatory affairs strategies and practices related to their assigned area of focus and expertise across BU, Regional and Central teams. Act as a strategic partner to Business Units and Regional Regulatory leaders, enabling aligned execution of regulatory strategies through tools, processes, and bestpractice sharing. This position requires technical expertise and a proven track record of successful registration strategies with a global mindset, leveraging global experience, standards, and intel. The role requires a significant understanding of the Regulatory function related to their area of focus and its associated activities. This role requires previous leadership of a diverse team, with the ability to coach, mentor, and lead.

**The location for this role is at our: Franklin Lakes, NJ Headquarters **

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

• Provide centralized regulatory intelligence and governance related to global product registration to interpret and execute on global regulatory requirements, ensuring timely insight and clear guidance to Business Units and Regions to enable compliant growth and market access.

• Own and standardize global regulatory registration processes, driving consistency, efficiency, and scalability across regions while allowing appropriate flexibility to meet local regulatory needs.

• Act as a strategic partner to Business Units and Regional Regulatory leaders, enabling aligned execution of regulatory strategies through tools, processes, and bestpractice sharing.

• Coordinates and networks across Business Units, Regions, Central RA, and other functions to influence, manage, and/or oversee global registration processes and programs and identify areas for improvement.

• Trains, develops, and manages a highly effective regulatory team through direct and indirect reporting structures. Works across business units and regional RA operations teams to harmonize key processes, escalate issues, and build communications channels across RA.

• Aids business units and functional groups in the creation of risk mitigation plans and solutions.

• Works across regulatory affairs teams to identify common pain points and potential solutions.

• Drive BD's global regulatory strategy and vision, in collaboration with regional leads, business leads, functional stakeholders.

• Stays apprised of global regulatory policy topics related to global product registration.

Minimum Qualifications:

• Bachelor's degree in science, engineering, or technology discipline required.

• Minimum 10 years of experience in Regulatory Affairs.

• Minimum 5+ years of relevant management and leadership experience with a track record of effectively leading people, projects, and business initiatives.

Preferred Requirements:

• Master's degree in business, management, or technology related field preferred.

• Experienced in both Business and Regional roles.

• Regulatory Affairs Certification (RAC).

Knowledge and Skills:

• Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of assigned projects, enlisting resources to efficiently meet project needs.

• Problem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make thorough regulatory assessments demonstrating the ability to solve difficult problems and create effective and innovative solutions.

• Decision Quality: Accurately assesses risk and clarifies ambiguous situations to make good decisions, developing alternatives based on risk assessment.

• Communication Skills: Able to present problems and recommendations to senior management effectively and accurately. Able to act as facilitator for small and large groups, and able to work with a diverse group of colleagues.

• Action Oriented: Demonstrates a significant bias for action to execute key objectives, while actively seeking other opportunities to contribute.

• Courage & Independence: Able to escalate issues as needed and make key decisions within area of focus.

• Composure: Responds constructively in stressful situations and able to drive to root cause of potential issues.

• Flexibility: Adapts plans to changing priorities, modeling and practicing key principles of change management.

• Process Effectiveness: Independently identifies the efficient ways to simplify and implement complex processes and able to reach out for help where needed.

• Process and Service Acumen: Thorough understanding of service-related processes and service engineering with ability to independently influence organizational direction.

• Organizational Agility: Is cognizant of organizational culture in a matrixed environment and appropriately adjusts personal style to be effective. Builds numerous and beneficial relationships through personal networks, inside and outside the organization.

• Influencing Others: Leverages internal or external experts or third parties to influence others towards an intended course of action

• Dealing with Ambiguity: Able to assess risk, competing needs and priorities and develop solutions.

• Building Effective Teams: Builds mission-driven, cohesive teams of people, sharing team wins and successes throughout the organization to instill team member value and appreciation.

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
• Potential reimbursement of phone use

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

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.

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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.

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