Regulatory Affairs Strategist, Globalization (Change Management)

Job Responsibilities

• Provide centralized regulatory governance related to the regulatory change management process.
• Able to interpret global regulatory requirements, ensuring timely insight and clear guidance to Business Units and Regions to enable compliant growth and market access.
• 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.
• Coincides and networks across Business Units, Regions, Central RA related to change management and helps to identify areas for improvement.
• Works across Business Unit and Regional RA operations teams to harmonize key processes, escalate issues, and build communications channels across RA.
• 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 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.
• 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.