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The person in this role may work remotely within the US or onsite at a US-based Medtronic facility.

CAREERS THAT CHANGE LIVES

The Medtronic Global Regulatory Affairs, Strategy & Policy 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 be a key contributor and advocate, with a primary responsibility of shaping U.S. medical device regulatory policy. Your success in this role is reliant on your ability and willingness to operate in a fast-paced, multi-tasking, geographically dispersed team environment.

You will be responsible for monitoring and influencing U.S. regulatory policies related to medical devices and advocating for Medtronic's interests at the US Food and Drug Administration (FDA). Your expertise and guidance will play a crucial role in shaping the regulatory landscape for Medtronic's medical devices, ultimately enhancing patient access to innovative healthcare solutions.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating 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. 

A DAY IN THE LIFE

  • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits, and inspections.
  • Leads or compiles all materials required in submissions, license renewal and annual registrations.
  • Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
  • Monitors and improves tracking / control systems.
  • Keeps abreast of regulatory procedures and changes.
  • May direct interaction with regulatory agencies on defined matters.
  • Recommends strategies for earliest possible approvals of clinical trials applications. 
  • Keeps abreast of U.S. regulatory guidelines, regulations, and policies related to medical devices and provided analysis of impact to Medtronic and communicate relevant updates to internal stakeholders.
  • Monitor industry trends and emerging U.S. regulatory issues impacting Medtronic’s business and regulatory environment.
  • Collaborate with cross-functional teams to identify regulatory challenges and develop advocacy strategies for addressing them.
  • May direct interaction with regulatory agencies on defined matters and engage with industry associations and other stakeholders to influence U.S. regulatory policy development.
  • Lead on commenting for external documents, including relevant U.S. regulatory guidance and regulation, and participate on external working groups, as needed. 
  • Work with regional SMEs to update, refine, and execute U.S. regulatory strategy, including meetings to understand developments, and identifying opportunities for advocacy/educational opportunities with regulators.
  • Work with project manager to keep up to date our Global Regulatory Policy SharePoint, including identifying commenting opportunities and keeping up to date our advocacy trackers. 
  • Lead work to develop talking points that can be utilized in U.S. regulatory advocacy work, and work with communications support to develop presentations for advocacy to regulators. 

MUST HAVE (Minimum Qualifications)

  • Bachelor’s degree
  • 10+ years of experience with a bachelor’s degree or 8+ years of experience with an advanced degree

NICE TO HAVE (Preferred Qualifications)

  • Strongly Preferred:

o Demonstrable understanding of U.S. FDA regulatory requirements and policy

o Regulatory experience within the medical device industry or a regulatory agency, such as the FDA

  • Exposure or experience in digital health
  • Ability to synthesize and present on complex technical topics
  • Strong interpersonal, oral, presentation, and written communication skills.
  • Flexible work hours to accommodate global stakeholders.
  • Demonstrated ability to work successfully in complex business and project areas. 
  • Ability to deal with ambiguity and changing environments, to learn quickly and teach others; flexible and able to adapt to shifting priorities.
  • Strong research and analytical skills
  • Experience with technical regulatory topics and strong working knowledge of device regulatory requirements
  • Innovative and strategic thinker
  • Self-starter 
  • Global mindset

ABOUT MEDTRONIC

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. 

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

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. Learn more about our benefits at http://benefits.medtronic.com.

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc. 

PHYSICAL JOB REQUIREMENTS

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America).

EEO STATEMENT

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.

DISCLAIMER

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

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Confirmed 16 hours ago. Posted 23 days ago.

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