Job Listing
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| Job ID: 14008222 |
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| Job Location: |
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| How to Apply: | To see employer contact information, log in or register. |
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| Job Title: | Senior Principal Regulatory Affairs Specialist |
| Work Type: | Work Days: Work Vary: Yes , Shift: Other, Hours Per Week: 40, Work Type: Regular |
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| Salary Offered: | Unspecified |
| Benefits: | Unspecified. |
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| Physical Required: | Unspecified |
| Drug Testing Required: | Unspecified |
| Education Required: | Bachelor's Degree |
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| Experience Required: | Unspecified |
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| Required Skills: | Please see the job description for information about required job skills. |
| Preferred Skills: |
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| Job Description: |
ABOUT INSPIRE MEDICAL SYSTEMS
Inspire 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 TEAM
At 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 POSITION
The Senior Principal Regulatory Affairs Specialist will provide regulatory support for both premarket and post market projects (e.g., PMA, IDE, and Qsub applications). There will also be opportunities for experience working on international projects. This individual will serve as a regulatory lead, providing guidance and support for cross functional teams.
OPPORTUNITIES YOU WILL HAVE IN THIS ROLE
Responsible for preparation and submission of regulatory applications
Providing regulatory affairs feedback and guidance to other functions
Prepare regulatory submissions
Negotiate and interact with regulatory bodies
Manage multiple projects and prioritize tasks
Collaborate with engineering, quality, clinical, operations, and other functions as needed
Develop and/or maintain departmental processes and SOPs to ensure compliance with changing regulations
Participate in internal and external audits as needed
Review analytical documentation to ensure they are appropriate for regulatory submission
Review device labeling and advertising materials for compliance with applicable regulations
Exhibit excellent writing skills, and attention to detail
Required Qualifications
Bachelor's degree in life sciences or other technical discipline preferred
Minimum 10 years of Regulatory experience in Medical Devices or an advanced degree with a minimum of 8 years medical device regulatory experience
Excellent organizational, communication and collaboration skill and ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources
Ability to compile data and summarize results
Thorough understanding of US regulations
Experience with PMA submissions
Experience in the neurestimulation field is highly desirable
Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, or any other status protected by applicable federal, state, and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.
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.
#LI-AM1
Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status with regard to public assistance, membership or activity in a local commission, military or veteran status, genetic information, or any other status protected by applicable federal, state and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.
Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that are in need of accommodations to complete the Inspire Medical Systems application process should contact Human Resources at 763-235-6742 or email careers@inspiresleep.com.
Refer to ID 78860530 when applying |
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