Principal Regulatory Affairs Specialist - Global Harmonization Policy & Key Initiatives

About this role

We anticipate the application window for this opening will close on - 28 Aug 2026   Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life                     LOCATION:   O nsite at a US-based Medtronic facility.   Preference for the   person to work EST hours.   

The Medtronic Global Regulatory Affairs team is looking for a highly motivated and skilled individual to join our Clinical Research, Medical Science, and Regulatory Affairs Organization. In this role, you will serve as a key contributor to Medtronic global regulatory advocacy and policy strategy, with a primary focus on advancing Global Harmonization for medical device regulations. You will monitor, interpret, and influence evolving global regulatory policies, develop high-quality advocacy positions and supporting materials, and provide clear guidance to internal stakeholders on key regulations and emerging issues. Your success in this role is reliant on your ability and willingness to operate in a fast-paced, multi-tasking, highly matrixed, and geographically dispersed team environment, partnering closely with regional subject matter experts and cross-functional teams. Your work will play a crucial role in shaping the global regulatory landscape for Medtronic's medical devices and supporting timely patient access to safe, effective, and innovative healthcare solutions.

We believe   innovation thrives when   people   with diverse backgrounds, experiences, and perspectives come   together   and everyone benefits .    Medtronic   fosters an inclusive culture where you can thrive.   Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers   to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are   and the life experiences they contribute .     We know equity starts beyond our workplace, and we must play a role   in addressing systemic inequities in our   communications   if we hope to have   long -term sustainable impact.  

Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees   and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world.  

Bring your talents to   an   industry leader in medical technology and healthcare solutions –   we’re   a market leader and growing every day. You can be proud to   be a   part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career .    We   encourage and   support your growth with the training, mentorship, and guidance you need to   own   your future success. Together, we can transform healthcare .     Join us for a career that changes lives .     Medtronic is committed to fostering a diverse and inclusive culture .    

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.    Responsibilities may include the following and other duties may be assigned:  

• Partner s   with regional   and functional   subject matter experts   to   define , align ,   and   execute s   global   regulatory   advocacy   strateg ies and action plans,   establishing   enterprise positions,   advocacy   priorities,   and coordinated   engagement   across all geographies , including regulator education opportunities .  

• Lead s   the   develop ment of relevant white papers   and   talking points that can be   utilized   in   global   regulatory advocacy work   by drafting content   and   soliciting   comments from   internal   stakeholders , and work with   appropriate team   members   and stakeholders   to develop presentations for advocacy to regulators.    

• Lead s   commenting   for   external documents ,   including relevant   guidances   and regulation,   and   participate   in   external working groups, as   directed .    

• Identif ies   and support s   the   development of internal resources   (e.g., playbooks, tools, training, and   subject matter expert   networks)   to   enable   enterprise -wide , globally harmonized   regulatory advocacy .  

• Lead s   and manage s   internal working groups , initially focused on priority global harmonization and regulatory policy initiatives,   to   provide   structured opportunities ( e.g.,   established   charters, forums, and expectations) for OU, functional, and   r egional   stakeholders   to collaboratively develop ,   shape , and evolve   enterprise   advocacy priorities.  

• May direct interaction with regulatory agencies on defined matters and engage with industry associations   and other stakeholders to influence   global   regulatory policy development.  

• Collaborate s   with   regional and   cross-functional teams to   emerging   or region-specific   regulatory challenges and   translate s   enterprise   advocacy   strategy into targeted, issue-specific advocacy actions .  

• Keeps abreast of   industry trends and emerging regulatory issues   impacting   Medtronic’s business and regulatory environment.  

• Works with   project manager to   maintain   and update the Global Regulatory Policy SharePoint,   including providing summaries of key policy updates,   identi fying   commenting opportunities, and   maintain ing   a

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