Regulatory Affairs Specialist

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 Cardiac Rhythm Management operating group is a division within Medtronic focused on developing and manufacturing medical devices and solutions for the management of cardiac arrhythmias and heart failure. This group's product portfolio includes implantable pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, and remote monitoring systems. CRM's mission is to improve patient outcomes and quality of life by providing innovative therapies for the detection, prevention, and treatment of abnormal heart rhythms. The group collaborates closely with healthcare professionals and leverages advanced technology and data-driven insights to drive improvements in cardiac care.

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 Mounds View, MN.

The Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory agencies to introduce cardiac arrhythmia and heart failures products and External Pacemaker to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with the license maintenance including renewals, design/manufacturing change notification, QMS audit, and Manufacturing site registrations.

Role and Responsibilities:

• Provide on-going support to project 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 Project 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.
• 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.
• Provide regulatory analysis of product portfolio and review with other functional resources, such as Marketing, Global Supply Chain, etc., to ensure Diagnostics and EPG portfolio is aligned with existing portfolio. Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
• Work under general supervision following established procedures. Independently determines and develops approach.
• Frequent inter-organizational contact and some external contacts.
• Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.
• Provide training and support to other members of the department.
• Other tasks, as required.

Must Have; Minimum Requirements

• Bachelor's degree in a technical discipline
• Minimum 2 Years of medical device regulatory experience with Bachelor's degree
• Or minimum 0 Years of medical device regulatory experience with an advanced degree

Nice To Have

• Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and PMDA), and working with cross-functional project teams.
• Master of Science Degree
• Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• Strong negotiation skills and written/oral communication skills
• Strong organizational skills and time management skills
• Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
• Ability to work independently and under general direction only
• Computer skills; MS Office, MS Project, Adobe Acrobat and Agile

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is 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. 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.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Join us in our mission to alleviate pain, restore health, and extend lifewhere your unique background and perspective are valued.

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):$74,400.00 - $111,600.00This 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

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.

If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair