Medtronic
Principal Regulatory Affairs Specialist -CRDN
Join to apply for the
Principal Regulatory Affairs Specialist -CRDN
role at
Medtronic . We anticipate the application window for this opening will close on 29 Sep 2025. 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 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. This role will be based in Santa Rosa, CA. 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 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. 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 to support compliant regulatory strategies. 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. 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 to mitigate challenges and keep objectives on track. Minimum Requirements 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 an 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 the software development life cycle. In-depth experience supporting software device development (SaMD, AI, Cybersecurity) and regulatory filings in the U.S., EU, and globally (IEC 62304/82304). 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; PMP is a plus. Working knowledge of Project Management methodologies and tools. Demonstrated strong business acumen and planning, and ability to drive to completion under aggressive schedules. Ability to manage multiple projects and proficiency with Microsoft Office and software tools. Physical Job Requirements The above statements describe the general nature and level of work performed by employees in this position and are not an exhaustive list of responsibilities. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For office roles: regular mobility, computer use, and interaction with peers are required. Benefits & Compensation Medtronic offers a competitive salary and flexible benefits package. Salary ranges for U.S. locations: $132,800.00 - $199,200.00. This position is eligible for the Medtronic Incentive Plan (MIP). The base salary range applies across the United States, with variations by location and experience. Benefits include health, dental and vision insurance, 401(k) with employer contribution, paid time off, holidays, and other programs described in the company benefits guide. About Medtronic Medtronic is a global leader in healthcare technology, dedicated to alleviating pain, restoring health, and extending life. We are committed to diversity and equal employment opportunity. See our detailed EEO statement in the full job posting. It is the policy of Medtronic to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, disability, race, religion, gender, sexual orientation, gender identity, or any other protected characteristic. Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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Join to apply for the
Principal Regulatory Affairs Specialist -CRDN
role at
Medtronic . We anticipate the application window for this opening will close on 29 Sep 2025. 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 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. This role will be based in Santa Rosa, CA. 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 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. 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 to support compliant regulatory strategies. 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. 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 to mitigate challenges and keep objectives on track. Minimum Requirements 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 an 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 the software development life cycle. In-depth experience supporting software device development (SaMD, AI, Cybersecurity) and regulatory filings in the U.S., EU, and globally (IEC 62304/82304). 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; PMP is a plus. Working knowledge of Project Management methodologies and tools. Demonstrated strong business acumen and planning, and ability to drive to completion under aggressive schedules. Ability to manage multiple projects and proficiency with Microsoft Office and software tools. Physical Job Requirements The above statements describe the general nature and level of work performed by employees in this position and are not an exhaustive list of responsibilities. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For office roles: regular mobility, computer use, and interaction with peers are required. Benefits & Compensation Medtronic offers a competitive salary and flexible benefits package. Salary ranges for U.S. locations: $132,800.00 - $199,200.00. This position is eligible for the Medtronic Incentive Plan (MIP). The base salary range applies across the United States, with variations by location and experience. Benefits include health, dental and vision insurance, 401(k) with employer contribution, paid time off, holidays, and other programs described in the company benefits guide. About Medtronic Medtronic is a global leader in healthcare technology, dedicated to alleviating pain, restoring health, and extending life. We are committed to diversity and equal employment opportunity. See our detailed EEO statement in the full job posting. It is the policy of Medtronic to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, disability, race, religion, gender, sexual orientation, gender identity, or any other protected characteristic. Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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