Regulatory Affairs Specialist

Medtronic

Regulatory Affairs Specialist supporting Medtronic’s medical device and suture regulatory submissions. Coordinating compliance, audits, inspections, and global regulatory activities.

Posted 8/28/2026full-timeNorth Haven • Colorado, Connecticut, Massachusetts, Minnesota • 🇺🇸 United StatesJuniorMid-Level💰 $74,400 - $111,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs for medical devices, including experience with U.S. FDA and international regulatory requirements. Proficient in managing regulatory submissions, audits, and inspections while ensuring compliance with relevant standards such as EU MDR and ISO 13485.

Highest-signal resume keywords

Regulatory SubmissionsU.S. FDA ExperienceEU MDR FamiliarityRAC CertificationCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceDocument PreparationClinical Protocol ChangesTracking and Control SystemsMedical Device Lifecycle Management

Soft Skills

Strong Written CommunicationStrong Verbal CommunicationOrganizational SkillsAbility to Manage Multiple Priorities

Certifications & Qualifications

RAC Certification

Industry Keywords

Absorbable SuturesNon-Absorbable SuturesInternal AuditsNotified BodiesGlobal Regulatory Agencies

About the role

Key responsibilities & impact

Support the Wound Management Regulatory Affairs team
Provide regulatory support for a diverse line of absorbable and non-absorbable, coated and uncoated sutures
Support sustaining globalization, international submissions, commercial support, manufacturing support, and systems improvement
Coordinate and prepare document packages for regulatory submissions, internal audits, and inspections
Lead or compile materials required for submissions, license renewals, and annual registrations
Recommend labeling, manufacturing, marketing, and clinical protocol changes for regulatory compliance
Monitor and improve tracking and control systems
Keep abreast of regulatory procedures and changes
Direct interaction with regulatory agencies on defined matters
Recommend strategies for earliest possible approval of clinical trial applications

Requirements

What you’ll need

Bachelor’s degree required
Minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience
For Baccalaureate degrees earned outside of the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
Unrestricted U.S. work authorization required at the time of hire and for the duration of employment
Experience with U.S. FDA and international regulatory requirements for medical devices
Familiarity with EU MDR, MDD, ISO 13485, ISO 14971, and related standards
Experience supporting regulatory submissions, audits, or inspections
Strong written and verbal communication skills
Strong organizational skills and ability to manage multiple priorities
Experience collaborating in a cross-functional, fast-paced environment
Familiarity with medical device product development or lifecycle management
RAC certification or progress toward certification
Experience working with Notified Bodies or global regulatory agencies

Benefits

Comp & perks

Competitive benefits package
Short-term incentive through the Medtronic Incentive Plan (MIP)
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 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
Capital Accumulation Plan for Vice Presidents and above, or subject to IRS earning minimums
Temporary employees: paid sick time as required by applicable state law and Employee Stock Purchase Plan