2 International Regulatory Affairs Specialist Jobs in Golden Valley, MN
SORT BY
I
I
International Regulatory Affairs Specialist
$81k-105k (estimate)
Full Time | Medical Technology
5 Days Ago
Inspire Medical Systems is Hiring an International Regulatory Affairs Specialist Near Golden Valley, MN
ABOUT INSPIRE MEDICAL SYSTEMSInspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Our focus on patient outcomes is at the core of everything we do, and our “think I can” attitude drives us to make a difference in the lives of those seeking alternative sleep apnea treatments.
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 POSITIONThe International Regulatory Affairs Specialist provides regulatory support for implantable neurostimulation therapy for the treatment of obstructive sleep apnea. This role will focus on manufacturing and design change assessments and vigilance activities for Asia Pacific geographies. This role will collaborate with in-country partners to meet regulatory objectives.
OPPORTUNITIES YOU WILL HAVE IN THIS ROLE
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.
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 POSITIONThe International Regulatory Affairs Specialist provides regulatory support for implantable neurostimulation therapy for the treatment of obstructive sleep apnea. This role will focus on manufacturing and design change assessments and vigilance activities for Asia Pacific geographies. This role will collaborate with in-country partners to meet regulatory objectives.
OPPORTUNITIES YOU WILL HAVE IN THIS ROLE
- Coordinate regulatory assessments of design and manufacturing changes, e.g., engineering change orders and supplier change requests.
- Work with technical experts in product development, quality, and clinical to address questions from regulatory agencies.
- Document field reports and complaints for regulatory reporting.
- Interact with international regulatory partners in local offices to support submission contents, as well as foreign regulatory agency reviewers to answer questions.
- Review labeling and promotional material for regulatory compliance.
- Bachelor’s degree
- International work and/or educational experience. Adaptability to international business cultures.
- Writing and communication skills.
- Medical device industry experience, in regulatory, quality, and/or engineering.
- Education and/or work experience in a technical or scientific field.
- Complaint handling and/or post-market change assessment experience.
- Foreign language ability, preferably in Asian geography.
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
JOB TYPE
Full Time
INDUSTRY
Medical Technology
SALARY
$81k-105k (estimate)
POST DATE
06/23/2024
EXPIRATION DATE
07/18/2024
WEBSITE
inspiresleep.com
HEADQUARTERS
MINNEAPOLIS, MN
SIZE
200 - 500
FOUNDED
2007
CEO
MARILYN CARLSON NELSON
REVENUE
$50M - $200M
INDUSTRY
Medical Technology
Related Companies
Show more
Similar Jobs
Popular Articles
Top 10 Things to Avoid Putting on a Job Application
Read Article
How to Describe Your Education in a Resume
Read Article
How to Write a Memorable Cover Letter in 5 Ways
Read Article
4 Personal Finance Tips to Make During Job Transition
Read Article
4 Best Camera Setups for Interview
Read Article
Keeping a Job Search Journal: 9 Types of Journaling You Can Do
Read Article
