Remote Regulatory Affairs Quality Assurance Specialist

Job Summary

A healthcare company has a current position open for a Remote Regulatory Affairs Quality Assurance Specialist.

Core Responsibilities Include:

• Providing guidance for standalone software design development and post market surveillance
• Supporting product and process improvement initiatives for the Quality Management System
• Initiating, developing and implementing all phases of regulatory strategy

Must meet the following requirements for consideration:

• Bachelor's Degree
• 3- 5 years experience in the medical device industry
• 5 years experience in a regulated environment working within CFR21 Part 820, ISO13485 and ISO14971
• 3 years with regulated software under the Software Development Process, the Agile Development Process and Cybersecurity
• Effective leadership skills
• Excellent collaboration and team building skills