Principal Regulatory Affairs Specialist - Global Harmonization Policy & Key Initiatives

Medtronic Global Regulatory Affairs Team Member

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.

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.

Responsibilities may include the following and other duties may be assigned:

• Partners with regional and functional subject matter experts to define, align, and execute 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 participates 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.

MUST HAVE (Minimum Qualifications)

• Bachelor's degree
• 7+ years of experience within the medical device industry or a regulatory agency with a bachelors degree or 5+ years of experience within the medical device industry or a regulatory agency with an advanced degree

NICE TO HAVE (Preferred Qualifications)

• 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.

Medtronic offers a competitive salary and flexible benefits package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD): $120,000.00 - $180,000.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.