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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.
Full Time
Medical Technology
$94k-120k (estimate)
03/08/2024
05/27/2024
medtronic.com
WASHINGTON, DC
>50,000
1949
Public
PETER B SLONE
$3B - $5B
Medical Technology
Medtronic is a medical technology and services firm that manufactures devices and therapies to treat for chronic diseases.