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Medtronic Diabetes is seeking a Principal Regulatory Affairs Specialist in Lafayette, CO, to provide regulatory leadership for its Acute Care & Monitoring product portfolio. The role involves developing and executing global regulatory strategies, collaborating with cross-functional teams, and mentoring junior regulatory professionals.
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Job Summary
The Principal Regulatory Affairs Specialist provides strategic leadership for the Core Respiratory product portfolio within the Acute Care & Monitoring unit.
This role requires leading global regulatory strategies across the entire product lifecycle, from early development to business wind-down activities.
Medtronic offers a competitive salary range of $120,000 to $180,000 along with comprehensive benefits including health insurance and 401(k) matching.
Matching Summary
Match Score: 75
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Medtronic Diabetes is seeking a Principal Regulatory Affairs Specialist in Lafayette, CO, to provide regulatory leadership for its Acute Care & Monitoring product portfolio. The role involves developing and executing global regulatory strategies, collaborating with cross-functional teams, and mentoring junior regulatory professionals.
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Salary
Base: $120,000.00 - $180,000.00 USD; Bonus/Equity: Eligible for Medtronic Incentive Plan (MIP); Benefits: Health, Dental, Vision, 401(k), Paid Time Off
Skills & Requirements
Must-have
Bachelor's degree required
7 years relevant experience
Global regulatory strategy execution
U.S. Class I and II device knowledge
EU MDR and ISO standards expertise
Nice-to-have
Mentoring junior regulatory staff
Direct agency interaction experience
Promotional material review skills
Business transition support
Cross-functional strategic partnership
Key Requirements
Minimum 7 years of relevant experience
Bachelor's degree in related field
Unrestricted US work authorization required
Expertise in 510(k) and PMA submissions
Knowledge of ISO 13485 and ISO 14971
Work Rights
Must have unrestricted US work authorization at time of hire