Senior Regulatory Affairs Specialist

Medtronic

Sr. Regulatory Affairs Specialist at Medtronic managing global regulatory submissions for Class II robotic devices.

Posted 5/15/2026full-timeBoston • Colorado, Connecticut, Massachusetts, Minnesota • 🇺🇸 United StatesSenior💰 $92,000 - $138,000 per yearWebsite

About the role

Key responsibilities & impact

Plan, develop, and execute global regulatory strategies and submissions for Class II robotic medical devices
Partner with Geography Regulatory Affairs for international submissions and government queries
Collaborate with R&D, Quality, Clinical, Manufacturing teams to maintain technical documentation
Support EU MDR technical documentation maintenance, audit and inspection readiness
Represent OUS regulatory function in new product development projects and regulatory compliance

Requirements

What you’ll need

Bachelor’s degree required
Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience
U.S. and international medical device regulatory submission experience, including FDA, EU, and global market pathways
Experience supporting Class II medical device approvals, registrations, renewals, and change notifications
Knowledge of international medical device regulations and standards, including US FDA, EU MDR, ISO 13485, and ISO 14971
Experience assessing regulatory impact of product, process, labeling, manufacturing, clinical, hardware, software, or design changes
Experience working with Geography RA partners, international regulatory teams, in-country affiliates, and cross-functional business partners
Strong technical writing, analytical, organizational, and project management skills
Ability to work independently, manage multiple priorities, and influence in a global matrixed environment

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
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
Capital Accumulation Plan

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategiesregulatory submissionstechnical documentationEU MDRFDAISO 13485ISO 14971medical device approvalsregulatory impact assessmentproject management

Soft Skills

technical writinganalytical skillsorganizational skillsability to work independentlymanage multiple prioritiesinfluence in a global matrixed environment

Certifications

Bachelor's degree