Regulatory Affairs Strategist, Globalization (eIFU/ Est. Registrations)





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Job Description

Job Summary:

The Regulatory Affairs Strategist, 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 assigned business practices through tools, processes, and best‑practice sharing. This position requires technical expertise related to labeling, eIFU, establishment registrations, device listings, and the ability to leverage 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.

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

• Provide centralized regulatory governance related global labeling requirements and information management, indlucing eIFU, ensuring timely insight and clear guidance to Business Units and Regions.
• Help to develop, own and standardize labelign, eIFU, establishment registration and device listing processes, driving consistency, efficiency, and scalability across business units and regions while allowing appropriate flexibility to meet local regulatory needs.
• Act as a strategic partner to Business Units and Regional Regulatory leaders, enabling implementation of labeling and eIFU processes and programs.
• Coordinates and networks across Business Units, Regions, Central RA, and other functions.
• 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.
• Stays apprised of global regulatory policy topics.

Minimum Requirements:

• Bachelor’s degree in science, engineering, or technology discipline required.
• Minimum 8 years of experience in the medical device industry, with at least 5 years in Regulatory Affairs.

Preferred Qualifications:

• Master’s degree in business, management, or technology related field.
• Experienced in both Business and Regional roles.
• Regulatory Affairs Certification (RAC).

Knowledge and Skills:

• Organization & Planning: 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 provide regulatory assessments and recommendations.
• 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...
• Action Oriented: Demonstrates a significant bias for action to execute key objectives.
• Courage & Independence: Able to escalate issues as needed, and make key decisions within area of focus.
• Composure: Responds constructively in stressful situations and escalate issues as needed..
• Flexibility: Adapts plans to changing priorities, modeling and practicing key principles of change management.
• Process Effectiveness: Works to identify ways to simplify and implement complex processes and able to reach out for help where needed.
• 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.

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 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

…