Regulatory Affairs Manager - Cardiovascular Surgery
Job Description
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 Cardiovascular Surgery Operating Unit is a specialized clinical environment designed to support complex surgical procedures involving the heart and major blood vessels. Equipped with advanced imaging systems, precision surgical instruments, and integrated patient monitoring technology, the unit enables surgical teams to perform procedures such as coronary artery bypass grafting, valve repair or replacement, and aortic surgery with high levels of accuracy and safety. The space is typically designed to facilitate multidisciplinary collaboration among surgeons, anesthesiologists, perfusionists, and nursing staff, while maintaining strict sterile protocols and efficient workflow to optimize patient outcomes.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 Ana, CA or Mounds View, MN.
The Regulatory Affairs Manager is responsible for leading a team of Regulatory professionals with responsibility for developing strategies and executing on regulatory submissions to introduce new products and therapies and maintain existing products to global markets.
Role and Responsibilities:
- Oversee team’s area of product responsibility, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports
- Provide input and direction to peripheral products in development and execution of market expansion opportunities
- Provide direction, leadership and coaching to staff to meet schedules, resolve technical or operational problems
- Direct interaction with regulatory agencies on defined matters.
- Keeps abreast of regulatory procedures and changes.
- Participate in audits and be part of field action teams
- Accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives.
- Recruit, develop and retain talent.
Must Have; Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
- Bachelor’s Degree
- Minimum 5 years experience in regulatory affairs for Class II and/or Class III medical devices
- Or advanced degree and a minimum 3 years experience in regulatory affairs for Class II and/or Class III medical devices
Nice to Have (Preferred Qualifications):
- Degree in a scientific/ engineering discipline
- Proven expertise in regulatory affairs, including, strategy planning, submission preparation, all phases of US FDA and EU MDR regulations, global regulatory requirements and procedures, negotiations, product design and development systems
- Cardiovascular device experience
- Experience interfacing with regulatory agencies
- Highly motivated and results-oriented leader
- Demonstrated supervisory and interpersonal skills
- Ability to flex and adapt to changing priorities
- Ability to handle advanced concepts and undefined paths
- Effective project management skills and experience
- Effective oral and written communication skills
- Ability to travel approximately 10%
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.
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.
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 life—where your unique background and perspective are valued.
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.
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.
Learn more about our business, mission, and our commitment to diversity here.
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 Chance Act.