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 Cardiac Ablation Solutions(CAS) division is focused on disrupting the Electrophysiology (EP) market to be the number one arrhythmia care pathway, cardiac mapping, and ablation solutions provider for our customers and patients. Inspired by the Medtronic mission and dedicated to transforming the lives of people with cardiac arrhythmias, to date CAS has transformed the lives of over 1 million patients.
Preference is for this position to be based in Mounds View, MN but a remote worksite may be considered.
The Senior Principal Regulatory Affairs will play a key role in providing regulatory affairs support for Class I, II and Class III medical devices.The Sr Principal Regulatory Affairs Specialist is responsible for activities to launching new products and sustain the current regulatory activities that lead to and maintain regulatory approval for medical devices primarily associated with ablation therapy that supports the diagnosis and treatment of atrial fibrillation. The Sr Principal Regulatory Affairs Specialist will work directly with development and sustaining teams to support regulatory activities throughout the product lifecycle. The Sr Principal Specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs specialist and in country specialists as needed, to support regulatory submissions worldwide for Class I, II, and Class III medical devices. Activities will include careful and clear documentation of regulatory decisions, authoring well written submissions to agencies, reviewing promotional materials, and ensuring that product technical documentation is current and accurate. Responsibilities are performed through the collaboration with various functions across the Operating Unit, including but not limited to Regulatory Affairs, Research and Development, Clinical, Quality, Operations, Global Supply Chain and Marketing and externally with regulatory bodies in the US, EU and other agencies as needed.
Responsibilities also include keeping senior management informed of the regulatory status of products and significant regulatory issues while continuously maintaining proficiency in global regulatory requirements.
The successful candidate will be able to deal with advanced concepts and undefined paths, work independently, develop new regulatory strategies and solutions based on experience and work collaboratively within the Regulatory department and other business functions. This position reports to the Senior Regulatory Affairs Manager.
Role And Responsibilities:
Develop and support global regulatory strategies for Class I, II, and Class III ablation therapy and diagnostic devices and the relevant accessories.
Responsible for identifying submission deliverables, timelines, and strategic direction. Reviews and approves technical documentation.
Provide feedback and work with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies and provide ongoing support to product development teams to assure timely resolution to regulatory issues and questions.
Prepare FDA, IDE and PMA and PMA supplements or 510(k) submissions for new products and product changes as required to ensure timely approvals to support clinical studies and market releases.
Negotiate with regulatory authorities to resolve questions/issues that arise prior to and during product submissions.
Interact directly with major market regulatory agencies in support of product registration, approval, and commercialization.
Participate in product change assessments and define the regulatory impact of product changes in global markets.
Provide support to market-released products. This includes reviewing labeling, product changes, manufacturing site transfer activities and documentation for changes requiring government approval.
Establish and maintain good relationships with agency personnel.
Collaborate with International RAS to understand worldwide regulatory requirements to enable the development of strategies and requirements for global commercialization.
Develop options of regulatory strategies, risks mitigation, issues and submission decisions/content and provide recommendations to the manager for decisions based on business impact.
Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work.
Must-Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
Bachelor's degree required.
Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience
Or minimum 5 years of medical device regulatory affairs experience with Master's degree
Preferred experience:
4+ years of medical device industry experience with US FDA 510(k) and EU MDR submission experience.
Proven expertise in all aspects of Regulatory Affairs; Strategy Planning, US and major market regulatory requirements, project management, and negotiations
Demonstrated ability to work well in dynamic and cross-functional team environments
Demonstrated collaboration and leadership skills in team setting
Solid understanding of manufacturing and change control, and an awareness of regulatory trends
Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
Effective interpersonal skills
Effective team member
Ability to comprehend principles of engineering, physiology and medical device use.
Good analytical and critical thinking skills.
Ability to effectively manage multiple projects and priorities.
International regulatory agency requirements, ISO I GHTF standards
Experience performing advertising and promotion reviews for medical devices
Product development experience
Working understanding of computer applications; proficient in Microsoft Office Applications
Minimal overnight travel required
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):$152,000.00 - $228,000.00
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).
Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)
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 (http://www.medtronic.com) .
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.
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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.
We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will...
Build a better future, amplifying your impact on the causes that matter to you and the world
Grow a career reflective of your passion and abilities
Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
Better outcomes for our world . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
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.
For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .
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