Senior Regulatory Affairs Specialist

Senior 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. In Coronary and Renal Denervation, we love what we do. That's because we're passionate about the patients we serve around the globe and the "second life" and improved health we can give to those with Coronary Artery Disease, High Blood Pressure, and other conditions. We're also driven by the promise of Renal Denervation and its potential to change the way patients around the world manage their uncontrolled hypertension. 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. This position will be based in Santa Rosa, CA or Mounds View, MN.

The Senior Regulatory Affairs Specialist will support Research and Development programs with pre-market regulatory strategy development for worldwide product registration with global regulatory agencies to introduce Coronary & Renal Denervation devices to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. This will include expertise in regulatory software development strategies (SaMD, AI, Machine Learning, Cybersecurity, etc.,) to support the operating units' (OU's) innovative pipeline. The specialist 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, supporting US and international submissions, change management assessments, the review and approval of advertising and promotional materials for commercial products across the CRDN portfolio and QMS audits as needed.

Role and Responsibilities :

• Act as a team member on development projects to provide regulatory guidance and develop global regulatory strategies and timelines for key markets.
• Author and prepare regulatory submissions for new products and their product changes as required to ensure timely approval for market release.
• Prepare regulatory strategies / plans taking inputs and incorporating worldwide compliance requirements. Provide on-going support to product development teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations.
• Provide business and product information to enable development of strategies and requirements, as well as communicate that information to the product development teams.
• Provide regulatory support for currently marketed products as necessary. This includes reviewing labeling and changes to existing devices and documentation. Prepare submissions and reports for regulatory agencies as required.
• Complete understanding and wide application of technical or regulatory principles, theories and concepts. General knowledge of other related disciplines.
• Negotiate with regulatory agencies, as needed.
• Participate in the project team meeting to plan strategies, including reviewing the various specifications and plans / reports, defining target market and distribution method, Medtronic requirements on testing, etc.
• Work under general supervision following established procedures. Independently determines and develops approach.
• Keep current on global directives, regulations harmonized standards and Medtronic procedures and communicate changes that may affect cross functional areas.
• Provide mentorship, training and support to other junior members of the department.
• Provide regulatory review and guidance for proposed product claims / labeling and advertising and promotional materials.
• Participate in inspections / audits either performed internally, by notified bodies, or by other international regulatory bodies.
• Assist regulatory department in the update, enhancement, and creation of internal policies and procedures.
• Support assessment and recommendation of new and changing regulations, guidance documents, requirements as needed.
• Other tasks, as required.

Must Have :

Nice To Have :

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.

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) : $103,200.00 - $154,800.00 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 : 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 95,000+ 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