Regulatory Affairs Manager – Cardiovascular Surgery

Medtronic

Regulatory Affairs Manager leading a team for regulatory submissions of medical devices. Overseeing product responsibilities and interacting with regulatory agencies for compliance.

Posted 6/4/2026full-timeSanta Ana • California, Minnesota • 🇺🇸 United StatesMid-LevelSenior💰 $120,800 - $181,200 per yearWebsite

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Hard Skills

regulatory affairsstrategy planningsubmission preparationUS FDA regulationsEU MDR regulationsglobal regulatory requirementsproduct designdevelopment systemsnegotiationsmedical devices

Soft Skills

leadershipcoachingmentoringinterpersonal skillsproject managementcommunication skillsadaptabilityresults-orientedsupervisory skillsproblem-solving

Certifications & Qualifications

Bachelor's Degreeadvanced degree

Industry Keywords

Class II medical devicesClass III medical devicesregulatory agenciesauditsfield action teamsCardiovascular device experience

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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
Degree in a scientific/ engineering discipline (Nice to Have)
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 (Nice to Have)
Experience interfacing with regulatory agencies (Nice to Have)
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%

Benefits

Comp & perks

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)