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Medtronic
Medtronic
H1B Visa SponsorHealthcareHealthcare InsuranceManufacturing
Medtronic is a global healthcare technology and manufacturing company developing solutions for complex medical conditions. Its work brings together large, international teams and close collaboration with healthcare professionals to improve treatments, therapies, and access to medical technology. With more than 95,000 employees across over 150 countries, Medtronic focuses on advancing patient care while supporting inclusion, diversity, equity, and sustainable practices across its operations.
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Regulatory Affairs Manager, Medical Devices — Medtronic (Hybrid, North Haven, CT)

Lead regulatory submissions, approvals, and compliance for Medtronic’s Surgical Operating Unit. Guide regulatory teams and cross-functional product strategies across the product lifecycle.

USUnited StatesCTConnecticutMAMassachusetts
$120,800 – $181,200 / year
HybridFull-timeMiddleSeniorEnglish RequiredCompliance

Description

  • Set global strategies for product approvals and regulatory submissions.
  • Prepare and execute U.S. and EU submissions.
  • Ensure products in the Surgical Operating Unit meet regulatory requirements.
  • Lead Regulatory Affairs contributors and assign responsibilities.
  • Work with business partners to shape regulatory strategies and turn them into team plans.
  • Act as regulatory lead on one or more new product development projects.
  • Direct the Stapling Regulatory Affairs team’s daily work.
  • Take on direct people management as business needs develop.
  • Address complex issues and keep schedules on track through hands-on operational work.
  • Create regulatory strategies for existing, new, and modified medical devices.
  • Work with regulatory authorities and stakeholders across functions.
  • Lead agency discussions during strategy development and regulatory reviews.
  • Advise teams on regulatory requirements for contingency planning and compliance.
  • Partner with quality, engineering, clinical, manufacturing, and commercial teams throughout the product lifecycle.
  • Oversee team performance, resource allocation, talent growth, succession planning, and employee engagement.
  • Review advertising and promotional materials for regulatory compliance.
  • Set performance expectations, coach team members, give feedback, and conduct evaluations.
  • Build a safe, inclusive, and engaging workplace.
  • Update senior management on progress toward product submission goals.
  • Improve operating practices, communication channels, and processes.
  • Prepare and coordinate documentation for submissions, internal audits, and inspections.
  • Lead or assemble materials for submissions, license renewals, and annual registrations.
  • Recommend updates to labeling, manufacturing, marketing, and clinical protocols.
  • Maintain and improve tracking and control systems.
  • Stay current with regulatory procedures and changes.
  • Engage directly with regulatory agencies on assigned matters.

Requirements

  • Bachelor’s degree required.
  • At least five years of relevant experience, or an advanced degree plus at least three years of relevant experience.
  • Five or more years in medical device regulatory affairs preferred.
  • Experience leading Regulatory Affairs for new product development projects preferred.
  • An engineering degree or an advanced degree preferred.
  • Demonstrated success leading high-performing teams preferred.
  • Ability to identify and develop key talent preferred.
  • Strong knowledge of U.S., European, and international regulations, including EU MDR, and applicable standards for products across risk classifications preferred.
  • Experience engaging with the FDA or other regulatory agencies preferred, including preparing Q-Submissions and meetings, submission issue meetings, and other agency interactions.
  • Ability to set priorities, manage time, and meet project deadlines preferred.
  • Ability to work effectively in a fast-changing, cross-functional team environment preferred.
  • For degrees earned outside the United States, a bachelor’s degree meeting the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
  • Unrestricted U.S. work authorization is required at hire and throughout employment for roles below Principal level.

Benefits

  • Competitive pay and a flexible benefits package.
  • Short-term incentive under the Medtronic Incentive Plan (MIP).
  • Medical, dental, and vision insurance.
  • Health Savings Account.
  • Healthcare Flexible Spending Account.
  • Life insurance.
  • Long-term disability leave.
  • Dependent care spending account.
  • Tuition assistance or reimbursement.
  • Simple Steps global well-being program.
  • Incentive plans.
  • 401(k) plan with employer contributions and matching.
  • Short-term disability coverage.
  • Paid time off.
  • Paid holidays.
  • Employee Stock Purchase Plan.
  • Employee Assistance Program.
  • Supplemental non-qualified retirement plan.
  • Capital Accumulation Plan for eligible employees.
  • Paid sick time for temporary employees where required by state law.

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