Principal Regulatory Affairs Specialist

Description

Job Summary

The Principal Regulatory Affairs position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device, and de novo devices). The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards.

Responsibilities

Regulatory Submissions and Compliance :

• Develop and implement global regulatory strategies to achieve market clearance in an effective and efficient manner
• Prepare, submit, and maintain product registrations, certifications, and approvals to meet US, EU and other regulatory requirements as applicable :
• 510(k) and / or De Novo submissions for FDA
• Technical documentation for EU MDR compliance
• International product registration activities to meet business objectives
• Interface with regulatory agencies (e.g., FDA, Notified Bodies) and respond to

inquiries.

Product Development Support :

Change Control Management :

Audits and Inspections :

QMS Support :

improvement activities

Qualifications

Education :

Experience :

Technical Skills :

Personal Attributes :

Inogen assesses market data to ensure a competitive compensation package for our employees.  The base salary for this position is expected to be between $99,000 and $119,000 annually. However, actual base salary if hired will be determined on an individualized basis and will be based on non-discriminatory factors, including as to individual skills, education, experience and market location.

Our Benefits and Rewards :

In addition to the expected base salary, this role is eligible to participate in Inogen’s annual performance bonus incentive plan, highly competitive and company-sponsored benefits, and wellbeing programs rooted in our strong culture of excellence. As a valued member of our team, Inogen provides health, dental, and vision insurance, 401(k) plan plus employer contribution and match, and generous paid leaves such as vacation and sick leave, including paid volunteer time, that can support you and your family through moments that matter.

Inogen is an Equal Employment Opportunity / Affirmative Action Employer - Underrepresented racial and ethnic groups / Females / Individuals with Disabilities / Protected Veterans.