Principal Regulatory Affairs Specialist, US Regulatory Policy at Medtronic in Annapolis, Maryland

Job Description:

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

LOCATION: The person in this role may work remotely within the US or onsite at a US-based Medtronic facility. Preference for the person to work EST hours.

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 be a key contributor and advocate , with a primary responsibility of shaping U.S. m edical 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 in relation to US Food and Drug Administration (FDA ) policy . 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

• Work s with regional SMEs to develop and execute U.S. regulatory advocacy strateg ies and action plans, including identifying opportunities for advocacy/educational opportunities with regulators.

• May direct interaction with regulatory agencies on defined matters and engage with industry associations , including AdvaMed , and other stakeholders to influence U.S. regulatory policy development.

• Keeps abreast of developing U.S. regulatory guidelines, regulations, and policies related to medical devices , provide s analysis of impact to Medtronic , and communicate s relevant updates to internal stakeholders.

• Monitor s industry trends and emerging U.S. regulatory issues impacting Medtronic's business and regulatory environment.

• Collaborate s with cross-functional teams to identify U.S. regulatory challenges and develop and implement advocacy strategies for addressing them.

• Lead s on commenting for external documents and participate on external working groups, as needed .

• Supports other team members in advancing global policy efforts, including commenting on key documents.

• Lead s 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.

• . Works with project manager to maintain and update the Global Regulatory Policy SharePoint, including providing summaries of key policy updates, identi fying commenting opportunities, and maintain ing advocacy trackers to support U.S. regulatory advocacy efforts.

• 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.

• Recommends strategies for earliest possible approvals of clinical trials applications.

MUST HAVE

• Bachelor's degree plus 7 + years of related experience within the medical device industry or a regulatory agency (or 5+ years with a n advanced d egree)

NICE TO HAVE

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

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

• Experience in advocacy related to healthcare policy and regulations.

• Ability to analyze complex information, identify key issues and develop strategic approaches.

• 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

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.

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.

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.

Salary ranges for U.S (excl. PR) locations (USD):$114,400.00 - $171,600.00

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

Medtronic benefits and compensation plans

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 90,000+ 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 .

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.

At Medtronic, most positions are posted on our career site for 3-7 days.