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
