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
The Global Standards Advisor is primarily responsible for leading and managing an enterprise-wide program to ensure that Medtronic business units are able to comply with regulatory requirements regarding international standards. This role provides leadership by establishing and coordinating an enterprise-wide working group on standards, ensuring that policies are in place to meet compliance; and provide focus and leadership to Medtronic Standards global activities. Additionally, this role will drive global standards-related activities, acting as the primary corporate contact and strategic internal consultant interacting with all
Medtronic functions in need for expert advice and training on all relevant activities related to Standards. The Global Standards advisor is also responsible for developing and implementing appropriate means of internal communications of issues, changes and best practices related to Standards across the corporation. This role influences the development of standards through participation in external standards organizations and other affiliated industry organizations as Medtronic’s primary representative, along with coordinating with other internal standards experts across the organization.
* Position is a Senior Manager level role
Responsibilities may include the following and other duties may be assigned.
Develop and maintain the Medtronic global standards strategy.
Establish and lead a cross-functional Standards Working Group to oversee the Medtronic standards management process.
Establish, update, and maintain policies to ensure compliance with regulatory requirements regarding standards.
Establish and maintain electronic libraries and other resources to ensure Medtronic-wide access to the most up-to-date standards.
Recommend budget for Medtronic standards activities, ensuring efficient allocation of resources.
Provide leadership, expert advice and assistance to all Medtronic functions regarding the development and use of standards relevant to the Medtronic business.
Develop, execute, and maintain internal communication programs to ensure all Medtronic functions have up-to-date information on standards and best practices.
Influence and contribute to the development of standards through active participation in external standards organizations and other affiliated industry organizations to advance Medtronic as a thought leader in standards.
Lead, collaborate, and coordinate with internal Standards experts to align and represent Medtronic position in external standards organizations and regulatory discussions.
Develop educational programs on use, interpretation and implementation of standards for employees across Medtronic.
Partner with process owner to execute enterprise-wide standards assessment process.
Must Have:
Bachelor’s Degree plus 7+ of regulatory experience including standards management experience within a regulated industry (5+ years with an advanced degree)
Nice to Have:
Master’s degree or 10+ years of standards management experience within a regulated industry
Prior Medical device experience
Experience with developing strategic work plans, Proven ability to work in a cross functional team and interact with all levels.
Strong interpersonal and written/verbal communication skills and presentation skills.
Ability to multi-task, support multiple small projects and functions on a global basis.
Solid understanding and application of business concepts, procedures and practices.
Detail and result oriented.
Experience managing global programs/projects
Demonstrated ability to understand regulatory affairs requirements and incorporate into business decisions and practices.
Comfortable with minimal supervision while maintaining good communication.
Solid collaborative, consultative and negotiating skills.
Strong analytical abilities coupled with creative problem solving skills.
Ability to influence change and implement change management.
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.
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