Bdx

Regulatory Affairs Strategist, Globalization (Change Management)

USA NJ - Franklin Lakes

Sponsorship not specified$138k-$220kDetected 2 days ago

FDA RegulatoryMedical DevicesCommunicationCollaborationProblem SolvingRegulatory Affairs

About the role

The Regulatory Affairs Manager, Globalization, is responsible for implementation of worldwide regulatory affairs strategies and practices related to their assigned area of focus and expertise across BU, Regional and Central teams.
The role requires an understanding of the Regulatory function related to their area of focus and its associated activities.
Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

Help to develop and standardize global change assessments, driving consistency, efficiency, and scalability across regions while allowing appropriate flexibility to meet local regulatory needs.
Act as a partner to Business Units and Regional Regulatory leaders, enabling implementation of global processes related to change assessments and notices of change.
Works across Business Unit and Regional RA operations teams to harmonize key processes, escalate issues, and build communications channels across RA.
Works to identify ways to simplify and implement complex processes and able to reach out for help where needed.
Able to assess risk, competing needs and priorities and develop solutions.

Bachelor's degree in science, engineering, or technology discipline required.
You can learn more on our career site under " Our Commitment to You."
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.

Master's degree in business, management, or technology related field.
Experienced Business and/or Regional roles.
Regulatory Affairs Certification (RAC).
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.
Communication Skills: Able to present problems and recommendations to senior management effectively...

Uses a combination of logic, analysis, and experience to provide regulatory assessments and recommendations.
Able to present problems and recommendations to senior management effectively...
Communication
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.

At BD, we are committed to supporting our associates' well-being, development, and success through a performance-based culture.
We are the people who give possibilities purpose

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 orientatio

This listing is sourced directly from Bdx's careers page and normalized into a canonical job model.