Principal Regulatory Affairs Specialist - Global Harmonization Policy & Key Initiatives
About The Position
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.
Requirements
- Bachelor’s degree
- 7+ years of experience within the medical device industry or a regulatory agency with a bachelor’s degree or 5+ years of experience within the medical device industry or a regulatory agency with an advanced degree
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Nice To Haves
- Proven experience leading complex, cross-functional and geographically dispersed working groups or teams, with responsibility for defining scope, governance, and deliverables and for facilitating effective collaboration and decision-making.
- Demonstrable understanding of international regulatory requirements, guidelines, and policy
- Experience in regulatory advocacy related to healthcare policy and regulations.
- Experience with the following technical regulatory topics: postmarket surveillance, MDSAP, clinical evidence, or human factors
- Clear written, verbal and visual communication skills, with the ability to synthesize complex regulatory information into white papers or presentations.
- Excellent relationship-building and collaboration skills across levels and geographies; ability to engage internal and external experts.
- Ability to deal with ambiguity and changing environments, to learn quickly and teach others; flexible and able to adapt to shifting priorities.
- Self-starter mindset with a passion for continuous learning, process improvement, and functional excellence.
- Flexible work hours to accommodate global stakeholders.
Responsibilities
- Partners with regional and functional subject matter experts to define, align, and executes global regulatory advocacy strategies and action plans, establishing enterprise positions, advocacy priorities, and coordinated engagement across all geographies, including regulator education opportunities.
- Leads the development 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.
- Leads commenting for external documents, including relevant guidances and regulation, and participate in external working groups, as directed.
- Identifies and supports the development of internal resources (e.g., playbooks, tools, training, and subject matter expert networks) to enable enterprise-wide, globally harmonized regulatory advocacy.
- Leads and manages 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 regional 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.
- Collaborates with regional and cross-functional teams to emerging or region-specific regulatory challenges and translates 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, identifying commenting opportunities, and maintaining advocacy trackers to support regulatory advocacy efforts.
- Leverages regulatory experience with technical domains to inform regulatory policy and support broader submission regulatory strategy, as needed.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
