RA QA Specialist
Company Summary:
My client, a medical device company dedicated to improving the lives of those impacted by cardiovascular disease is looking to add a Regulatory Affairs/Quality Assurance Specialist to their team! They have developed first-in-class products for helping to detect warning signs in patients impacted by cardiovascular disease.
The RA/QA Specialist will be responsible for:
- Assisting in preparation for and during inspection of the company's quality system by outside regulatory agencies
- Providing QA support to all QMS functions
- Developing and managing all regulatory submissions (including US pre-market approvals, international design dossiers, post-approval reports)
The RA/QA Specialist should have the following qualifications:
- Bachelor's degree and 5+ years of experience in a FDA regulated industry
- Knowledge of US medical device regulations
