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Senior Regulatory Affairs Lead — Hybrid; FDA​/Health Canada

Job in Lone Tree, Douglas County, Colorado, 80124, USA
Listing for: Cochlear Limited
Full Time position
Listed on 2026-03-01
Job specializations:
  • Healthcare
    Healthcare Management
Salary/Wage Range or Industry Benchmark: 120000 - 130000 USD Yearly USD 120000.00 130000.00 YEAR
Job Description & How to Apply Below
Position: Senior Regulatory Affairs Lead — Hybrid (FDA/Health Canada)
A leading medical device company is seeking a Senior Regulatory Affairs Specialist in Lone Tree, Colorado. This hybrid role requires a minimum of 5 years of regulatory experience, particularly in FDA submission writing. The successful candidate will manage regulatory strategies, write submissions, and liaise with health authorities to ensure compliance with medical device regulations. They will contribute to product launches and be an essential part of multi-functional teams.

Competitive salary between $120,000 - $130,000, plus a bonus opportunity.
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Position Requirements
10+ Years work experience
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