Prin Regulatory Affairs Spec - Global Harmonization

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

This role serves as a key driver of Medtronic’s global regulatory advocacy and policy strategy, with a primary focus on advancing global harmonization of medical device regulations. The individual partners closely with regional and cross functional experts to monitor, interpret, and influence evolving regulatory policies, develop enterprise advocacy positions and high quality materials, and lead coordinated engagement with regulators and industry groups worldwide. Operating in a fast paced, highly matrixed, and global environment, the role translates complex regulatory issues into clear guidance and targeted actions that support timely patient access to safe, effective, and innovative medical technologies.Responsibilities may include the following and other duties may be assigned:

• Define, align, and execute global regulatory advocacy strategies in partnership with regional and functional SMEs, with emphasis on global harmonization
• Develop and lead high-quality advocacy materials (white papers, talking points, presentations) and coordinate enterprise-wide input and alignment
• Lead external commenting on regulations and guidances; participate in industry working groups and engage with regulators and associations as directed
• Establish and manage internal working groups, tools, playbooks, and training to enable coordinated, globally harmonized advocacy
• Monitor global regulatory trends and emerging issues, translate enterprise strategy into targeted regional actions, and maintain advocacy trackers and SharePoint resources

Required Knowledge and Experience:

• Bachelor's Degree
• Five to seven years of experience in regulatory advocacy and influencing healthcare policy in a global, matrixed environment.
• Strong understanding of international medical device regulations, guidelines, and regulatory policy frameworks.
• Technical regulatory knowledge across key areas such as postmarket surveillance, MDSAP, clinical evidence, and/or human factors.
• Excellent written, verbal, and visual communication skills to synthesize complex regulatory concepts into clear, persuasive materials

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

Benefits & Compensation

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.
 

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

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here