Position Summary:
A Regulatory and Quality Associate is an entry level position with a focus on documentation of FDA records/reports, 510k submission materials, training materials, quality assurance activities, and continuous improvement processes. The goal is to deliver superior medical device hardware and software products to our internal and external customers.
Essential Functions:
- Participate in any 510k initiatives including research and documentation
- Participate in internal and vendor audits
- Create and maintain controlled documents
- Identify methods to improve our testing efficiency and time to find issues
- Become knowledgeable about the ReactDx Quality System Manual
- Conduct activities in accordance with FDA Design Controls
- Comply with FDA guidelines, standards, and business defined documentation processes to provide quality deliverables
- Perform all other duties as assigned
Supervisory Responsibility
This position has no supervisory responsibilities.
Required Education and Experience
- 4 year degree from an accredited college
- 2 years of experience in an FDA regulated industry, preferably medical device a plus
- Knowledge of FDA Title 21, Part 820 and ISO13485
- Knowledge of medical device industry
- Knowledge of JIRA, Confluence, and TestRail is a plus
- Excellent writing skills
- Proficient in Microsoft Office software and Google applications
- Organized, able to take instructions, work in a time sensitive environment, and be able to solve problems independently and/or under limited supervision
- Ability to work in a team-oriented environment as well as individually
- Ability to adapt to changing priorities
- Ability to learn quickly