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Senior Regulatory Affairs Program Manager
MedtronicLeads regulatory submissions and compliance strategies within Medtronic's Neuroscience portfolio. Driving innovation in medical technology to alleviate pain and restore health for patients.
Posted 5/22/2026full-timeRemote • Tennessee • 🇺🇸 United StatesSenior💰 $154,400 - $231,600 per yearWebsite
About the role
Key responsibilities & impact- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections.
- Leads or compiles all materials required in submissions, license renewals, and annual registrations.
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Monitors and improves tracking/control systems.
- Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.
- Recommends strategies for the earliest possible approvals of clinical trial applications.
Requirements
What you’ll need- Requires a Baccalaureate degree
- Minimum of 7 years of relevant experience, or an advanced degree with a minimum of 5 years of relevant experience
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
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
- Simple Steps (global well-being program)
- 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 (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
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Soft Skills
coordinationpreparationleadershiprecommendationmonitoringimprovementinteractionstrategy development
Certifications
Baccalaureate degreeadvanced degree