Inspire Medical Systemshas developed the only FDA-approved neurostimulation technology that transforms the lives of people with moderate to severe sleep apnea. We are a ground-breaking, fast-growing company where the patient’s outcome is first and foremost our top priority.  If you want to become part of a purpose-driven company and directly help to transform lives, this is the perfect career opportunity for you!

Position Summary:

This position represents an opportunity to apply regulatory expertise to a first of its kind therapy for a growing company.  As Senior Manager of Regulatory Affairs, this individual will provide direction and leadership in the development and implementation of regulatory strategies and processes to assure timely global commercialization of products, and continued compliance with applicable regulations and standards.  

MAIN DUTIES/RESPONSIBILITIES

• Act as a regulatory representative on core product development teams developing and communicating regulatory strategy, requirements, and impact of regulations.
• Serve as a liaison between Inspire and various regulatory agencies
• Provide work direction and training to direct reports.
• Provide regulatory guidance to other departments.
• Review and approve product and manufacturing changes to assure compliance with regulatory requirements.

QUALIFICATIONS

Educational Requirements:

• Required: Bachelor’s degree in science, engineering, technology, or biomedical discipline.
• Preferred: Master’s degree in a technical or scientific field.

Required Experience:

• Minimum of 8 years of experience in regulatory affairs.
• Working directly with FDA
• Proven history of formulating successful regulatory strategies that meet aggressive preparation and approval timelines, while maintaining the highest level of quality.
• Expertise in all aspects of regulatory affairs; strategy, planning, and submission preparation.

Preferred Experience:

• Regulatory responsibility for active implantable medical devices, devices containing software, and software as a medical device.
• Regulatory responsibility for multiple function device products, i.e. devices with both medical device and non-medical device software functions.
• Experience working with the CRDH Division of Digital Health
• Experience working with Notified Bodies, PMDA, and TGA. 
• Proven success in coaching, developing, and managing people.
• Effective relationship management, ability to network, support and influence across functional groups

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 dot com.

Inspire Medical Systems participates in E-Verify.