As the Sr. Principal Master Black Belt, Global Regulatory Affairs, you will be responsible for overseeing and/or executing the process components of the functional transformation strategy. You will have visibility to all facets of this endeavor and a unique opportunity to grow and shape the future of Medtronic.
This role will report to the Sr. Program Manager, Regulatory Affairs Transformation and be a member of the Global Transformation Core Team.
Responsibilities may include the following and other duties may be assigned.
• Passionately advocate for and drive process excellence across the Regulatory Affairs
Function; advocate and influence appropriate continuous improvement needs across
Medtronic by providing process-related analytical, project management, facilitation or
consulting skills based on business demands and strategic priorities; advocate for process
excellence and strive for ‘Breakthrough Improvement’ in all projects.
• Define and provide the tools, techniques and methodologies required for process-related
improvements and process excellence; ensure programs are integrated vertically and
horizontally across the organization; coach or mentor colleagues and teams to advance
projects as needed.
• Routinely apply Lean Sigma, PM skills or change management tools to complex
continuous improvement problems and opportunities, and enable the development and
sustainable implementation of viable, data-driven initiatives and solutions that resonate with
• Work collaboratively with, and influence leaders and teams across, all hierarchical levels,
business units and geographies; act as a liaison between Corporate, the business units,
geographies, and functional partners; Create and maintain excellent working relationships with
critical stakeholders and the teams assigned; develop communication feedback loops as
required and escalate issues as needed.
• Reliably align with leadership on priorities and ensure program activities, decisions
measurements and metrics drive respective strategies; inform strategic plans; provide input to
leadership presentations articulating strategy or facilitate steering committee discussions and
other reviews, workshops or team meetings.
• Lead, monitor and be accountable for assigned program and portfolio results from initiation
to successful completion as defined by leadership; establish and maintain performance metrics
and deliver measurable, relevant and meaningful results.
• Provide insight and foresight into achieving company objectives, including proactively
assessing, verifying and measuring process effectiveness, identifying and proposing the
modification and enhancement of processes to be more efficient and exploring and
incorporating local or global best practices; identify new opportunities through data-driven and
propose plans, projects, and initiatives that capitalize on these opportunities.
• Inform process excellence for overall program governance, project reviews, communications,
training, certifications and rewards.
• Lead project work streams or provide project management support as needed.
Must Have: Minimum Requirements
• Bachelor’s Degree in engineering, business or other technical discipline
• 10+ years of experience in working in a highly regulated industry (8+ years with advanced
• Lean Six Sigma Black Belt Certified
Nice to Have
· MBA or related graduate degree. · Medical Device Experience. · Regulatory Affairs functional experience. · Ability and interest in working fully independently to implement strategic goals and establish operational plans; ability to self-initiate assignments and proactively ensure that the necessary tasks get accomplished. · Experience analyzing complex issues and making business-level recommendations to improve, change or adapt new methods or ways of working. · Ability to influence deliver value-added improvements and change in a pragmatic, timely manner working within defined best practices and standards while thinking outside the box. · Strong ability to interface, influence, and build effective relationships and partnerships at all organizational levels. · A track record of demonstrated ability to create and execute to plans. · An independent thinker with the proven ability to create and leverage influential networks of professional resources. · Progressive mind-set, innovative thinking (always looking for improvement opportunities). · Data-driven mindset and excellent understanding of data analytic and reporting tools, capable of explaining the underlying concepts and principles to demonstrate business impact opportunities or results. · Ability to move strategy from concept through implementation to realization. · Flexible and able to adapt to shifting priorities in a dynamic and changing environment.