Job Details

Principal Regulatory Affairs Specialist

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.

The Coronary and Renal Denervation (CRDN) division is focused on therapies that are a vital component of the Medtronic interventional cardiology portfolio. In addition to our core products that treat blocked coronary arteries, we are seeking to solve unmet needs in the rapidly growing field of complex percutaneous coronary intervention (PCI) while leading the way with the transformational renal denervation therapy, recently approved in the U.S. and which has the potential to be a powerful tool in battling the global hypertension epidemic. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Join a diverse team of Regulatory Affairs Professionals who bring their knowledge, their unique backgrounds, and their experiences to work every day. It's no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

The Principal Regulatory Affairs Specialist will support Research and Development programs with early phase pre-market regulatory strategy development with a view through the full product lifecycle. Bringing hands-on expertise in regulatory software development strategies (SaMD, AI, Machine Learning, Cybersecurity, etc.,) to support the operating units' (OU's) innovative pipeline is key. This individual will support maintaining a strong foundation for future software product development for the Regulatory Function and may also support broader Medtronic enterprise working groups focusing on staying informed and current with global regulation and guidance updates in the digital health space. Additionally, the Principal Regulatory Affairs Specialist is expected to play a key role in the mentoring of junior team members and to be an active participant in the development and training of the Regulatory Affairs team. The individual will work in collaboration with Regulatory Affairs Team members, cross functional members at varying levels within the organization as well as International Regulatory Affairs staff. Strategic direction is expected to support a number of regulatory applications which may include, FDA Pre-submissions, PMDA consultations, original IDEs and PMAs, IDE and PMA Supplements/Reports, Shonin applications, and EU MDR Technical Documentation in addition to Change Management assessments. The successful candidate will actively support advertising and promotion activities for commercial products across the CRDN portfolio, may support audit and compliance activities as needed and support business development activities/needs as they arise.

Role and Responsibilities

• Works with OU Regulatory Affairs management and staff to build and/ or increase knowledge base in software product development in the digital health space (SaMD, AI, Cybersecurity, etc.).
• Provide tactical and operational support for digital health programs to ensure compliance with applicable regulations and guidance documents.
• Serve as a regulatory liaison for digital health initiatives, ensuring timely execution of deliverables in alignment with broader program goals
• Represents the Regulatory Affairs function on product development teams, bringing the voice of the function to discussions in an effort to support creative and compliant regulatory strategies for the program.
• Partners with cross-functional team members to lead engagements with regulatory agencies for new and existing devices.
• Leads and influences the preparation of documentation to support innovative and high-quality regulatory submissions from early phase strategies, marketing applications, and change management implementation.
• Engage and actively participate in compliance activities (preparation and execution) including identification of opportunities for improved efficiencies within processes.
• Acts as a mentor to colleagues within the team and effectively manages an extended team.
• Stays current on regulation and guidance changes supporting advocacy work as needed to influence evolving regulatory requirements.
• Works with functional team members to ensure clear communication of project/program objectives, deliverables, and timing of key milestones.
• Partners in problem resolution in an effort to mitigate functional/ program level challenges to keep objectives moving in line with program estimates.
• Works within a matrixed, collaborative team environment that fosters professional development while focusing on meeting business objectives driven by standards of excellence.

Must Have; Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

• Bachelor's degree in a technical discipline
• Minimum of 7 years of direct Regulatory Affairs experience within the medical device or other regulated industry,
• Or advanced degree with a minimum of 5 years of Regulatory Affairs experience.
• Medical device industry experience with Class I/II/III/IV software products.

Nice To Have:

• Direct Regulatory Affairs experience supporting programs throughout software development life cycle.
• In depth experience supporting successful software device development (SaMD, AI, Cybersecurity, IEC 62304/82304) and associated regulatory filings in the U.S., EU, and globally.
• Experience performing advertising and promotion reviews/approvals for medical devices.
• Experience engaging regulatory bodies.
• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
• Analytical, process and data visualization experience.
• Working knowledge of Project Management methodologies and tools; PMP certification is an asset.
• Demonstrated strong business acumen and planning.
• Strong interpersonal, quantitative analysis, and problem-solving skills.
• High degree of initiative and influence management skills.
• Experience working in a hybrid team environment in supporting cross-functional teams remotely.
• Results oriented. Ability to drive to completion in adherence to aggressive project schedules.
• Ability to manage multiple projects and proficiency with Microsoft Office and software tools.

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):$132,800.00 - $199,200.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: