Regulatory Affairs Manager

Medtronic•North Haven, CT

1d•Onsite

About The Position

The Regulatory Affairs Manager establishes worldwide product approval and submission strategies, directly executes submission activities focused on the U.S. and EU, and ensures regulatory compliance for products within Medtronic’s Surgical Operating Unit. The role combines hands-on leadership with delegation to individual contributors, and works with business partners to align regulatory strategies with business goals and translate them into team work plans. The position is onsite four days per week at a Surgical location: North Haven, CT (preferred), Lafayette, CO, Mounds View, MN, or Mansfield, MA. The manager may serve as regulatory lead for new product development projects and oversee the day-to-day activities of the Stapling Regulatory Affairs team. The role may assume direct people-management responsibilities as business needs evolve. It includes developing strategies for existing, new, and modified medical devices; coordinating with external regulatory authorities and cross-functional stakeholders; supporting regulatory reviews; maintaining compliance; and overseeing regulatory review of advertising and promotional materials. The manager also leads team performance, resource planning, talent development, succession planning, employee engagement, and continuous improvement. The position coordinates and prepares documentation for submissions, audits, and inspections; supports license renewals and annual registrations; and provides progress reports to senior management. The application window is anticipated to close on November 4, 2026. The position is eligible for the Medtronic Incentive Plan (MIP). The listed U.S. salary range, excluding Puerto Rico and specified California locations, is $120,800 to $181,200.

Requirements

Bachelor’s degree required.
At least 5 years of relevant experience, or an advanced degree and at least 3 years of relevant experience.
For a baccalaureate degree earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
Must possess unrestricted U.S. work authorization at the time of hire and for the duration of employment; sponsorship is offered exclusively for Principal-level roles and above.
Ability to work onsite four days per week at one of the listed Surgical locations.
Ability to prioritize work, manage time effectively, and meet project deadlines.
Ability to work effectively in dynamic, cross-functional team environments.

Nice To Haves

Five or more years of medical device regulatory affairs experience.
Experience serving as a Regulatory Affairs lead for new product development projects.
Degree in engineering or an advanced degree.
Proven track record of leading high-performing teams and ability to recognize and develop key talent.
Excellent knowledge of U.S., European, and international regulations, including EU MDR, and standards applicable to products of all risk classifications.
Experience interacting with the FDA and/or other regulatory agencies, including preparation for Q-Submissions and meetings, submission issue meetings, and other interactions.

Responsibilities

Establish worldwide product approval and submission strategies, and directly execute submission activities focused on the U.S. and EU.
Ensure regulatory compliance for products within the Surgical Operating Unit.
Translate regulatory strategies into work plans for Regulatory Affairs teams in collaboration with business partners.
Serve as regulatory lead for one or more new product development projects, as applicable.
Oversee day-to-day regulatory activities of the Stapling Regulatory Affairs team and potentially assume direct people-management responsibilities as business needs evolve.
Participate in daily operations to meet schedules and resolve complex problems.
Develop regulatory strategies for existing, new, and modified medical devices to meet business objectives and support global product success.
Collaborate with external regulatory authorities and cross-functional stakeholders, and lead agency interactions supporting strategy development and regulatory reviews.
Provide guidance on regulatory requirements for contingency planning and ensure compliance with applicable regulations.
Partner with quality, engineering, clinical, manufacturing, and commercial teams to ensure regulatory compliance throughout the product lifecycle.
Manage team performance, resource planning, talent development, succession planning, and employee engagement initiatives.
Oversee regulatory reviews of advertising and promotional materials to ensure product claims and materials comply with local guidance and regulations.
Set clear performance expectations; coach and provide feedback; develop team members; communicate talent differentiation; conduct timely performance evaluations; and align development actions and rewards.
Cultivate a safe, inclusive, and engaging work environment.
Provide progress reports or presentations to senior management regarding Operating Unit product submission goals.
Improve operating mechanisms, communication pathways, and processes to increase efficiency.
Direct or coordinate preparation of document packages for regulatory submissions, internal audits, and inspections.
Lead or compile materials required for submissions, license renewals, and annual registrations.
Recommend changes to labeling, manufacturing, marketing, and clinical protocols to maintain regulatory compliance.
Monitor and improve tracking and control systems, and keep abreast of changes to regulatory procedures.
Potentially direct interactions with regulatory agencies on defined matters.

Benefits

Competitive salary and flexible benefits package.
Medtronic Incentive Plan (short-term incentive).
Health insurance.
Dental insurance.
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 with 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 for Vice Presidents and above, or subject to IRS earning minimums.