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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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Medical Device Regulatory Affairs Manager

Lead regulatory strategy, submissions, and compliance for Medtronic medical devices, with a focus on U.S. and EU approvals. Guide the Stapling Regulatory Affairs team and work across product development and business functions.

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

Description

  • Set global strategies for product approvals and regulatory submissions.
  • Prepare and submit regulatory filings for the U.S. and EU.
  • Maintain regulatory compliance for products in the Surgical Operating Unit.
  • Lead hands-on work and delegate effectively to individual contributors.
  • Work with business partners to shape regulatory strategies around business goals and turn them into team plans.
  • Lead regulatory affairs for one or more new product development projects.
  • Direct daily regulatory work for the Stapling Regulatory Affairs team.
  • Take on direct people-management duties as business needs require.
  • Engage in daily operations to meet schedules and resolve complex issues.
  • Create regulatory strategies for existing, new, and modified medical devices.
  • Coordinate across a matrixed organization to support global product success.
  • Lead regulatory agency interactions and support regulatory reviews.
  • Advise on regulatory requirements for contingency planning and help ensure compliance.
  • Partner with quality, engineering, clinical, manufacturing, and commercial teams throughout the product lifecycle.
  • Oversee team performance, resource planning, talent growth, succession planning, and employee engagement.
  • Review advertising and promotional materials for regulatory compliance.
  • Coach employees, provide feedback and performance evaluations, and support their development.
  • Promote a safe, inclusive, and engaging workplace.
  • Update senior management on product submission goals at regular intervals.
  • Improve operating practices, communication channels, and processes.
  • Prepare and coordinate document packages 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.
  • Monitor and strengthen tracking and control systems.
  • Stay current with regulatory procedures and changes.
  • Interact directly with regulatory agencies on assigned matters.

Requirements

  • Bachelor’s degree.
  • At least 5 years of relevant experience, or an advanced degree and at least 3 years of relevant experience.
  • At least 5 years of regulatory affairs experience in medical devices.
  • Experience leading regulatory affairs for new product development projects.
  • A degree in engineering or an advanced degree.
  • A track record of leading high-performing teams.
  • Ability to identify and develop key talent.
  • Strong knowledge of U.S., European, and international regulations, including EU MDR, and standards for products across risk classifications.
  • Experience working with the FDA or other regulatory agencies, including preparing Q-Submissions and meetings, submission issue meetings, and other agency interactions.
  • Ability to prioritize work, manage time, and meet project deadlines.
  • Ability to work effectively in dynamic, cross-functional teams.
  • For degrees earned outside the United States, a baccalaureate degree meeting the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
  • Unrestricted U.S. work authorization at hire and throughout employment.

Benefits

  • Competitive pay and a flexible benefits package.
  • Medical, dental, and vision coverage.
  • 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.
  • Non-qualified retirement plan supplement.
  • Capital Accumulation Plan for vice presidents and above, or employees meeting IRS earnings thresholds.
  • Temporary employees receive paid sick time as required by applicable state law and may participate in the Employee Stock Purchase Plan.
  • Medtronic Incentive Plan (MIP), a short-term incentive.

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