Regulatory Affairs Specialist, III

Description

Job Summary

The Regulatory Affairs Level III (Senior Specialist) 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 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
• Provide regulatory input to support product labeling
• Monitor new and changing regulatory requirements and ensure the business understands relevant impacts
• Lead corrective and preventive action (CAPA) efforts as assigned

Product Development Support :

Change Control Management :

Audits and Inspections :

QMS Support :

Qualifications

Education :

Experience :

Technical Skills :

Personal Attributes :