Regulatory Affairs Manager - Cardiovascular Surgery

Medtronic•Mounds View, MN

5d•$120,800 - $181,200•Hybrid

About The Position

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.

Requirements

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
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.

Nice To Haves

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%

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.

Benefits

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
Simple Steps (global well-being program)
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)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)