1 Sr. Regulatory Affairs Specialist Job in Golden Valley, MN
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Inspire Medical Systems is Hiring a Sr. Regulatory Affairs Specialist Near Golden Valley, MN
WHY JOIN OUR FAST-GROWING TEAMAt Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering hybrid work schedules, excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.
If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team!
ABOUT THIS POSITIONWe are recruiting a Sr. Regulatory Affairs Specialist to join Inspire Medical Systems located in Minneapolis, MN. In this role, you will be a member of a small, cross functional team focusing on a strategic initiative. It will be a fast-paced environment where you will contribute to multiple different roles.
OPPORTUNITIES YOU WILL HAVE IN THIS ROLE
- Evaluate international geographic requirements for clinical studies and select geographies that align with Inspire’s strategic goals
- Interact directly with FDA and international regulatory agencies to author submissions and coordinate with the governing body for clinical studies
- Work with technical experts in product development, quality, and clinical to generate project deliverables and to address questions from regulatory agencies.
- Generate and approve design history file documents, device master record documents, engineering change order records, and other quality system documents and records as assigned.
- Bachelor’s degree
- 5 years minimum experience in medical device industry
- Demonstrated team leadership skills and ability to prioritize, execute and report on projects
- Ability to work on multiple tasks concurrently with changing priorities
- Regulatory Submission Experience (FDA, EU, PMDA, TGA)
- Degree in scientific or technical field
- 10 years minimum experience in medical device industry
Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep(dot)com
Inspire Medical Systems participates in E-Verify.
Job Summary
Full Time
Medical Technology
$91k-116k (estimate)
05/24/2024
05/30/2024
inspiresleep.com
MINNEAPOLIS, MN
200 - 500
2007
MARILYN CARLSON NELSON
$50M - $200M
Medical Technology
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