Regulatory & QA Specialist I/II
- Handle FDA and regulatory submissions, such as pre-submission and marketing applications.
- Assist the clinical collaborations by providing compliance and trial design expertise.
- Aid in development of standard regulatory procedures.
- Help develop and maintain QMS.
Requirements of the Regulatory & QA Specialist I/II:
- BS/MS, ideally in life science related discipline.
- 2+ year of regulatory affairs & QA experience.
- Previous experience with molecular diagnostics is helpful.
- Experience with quality systems in regulated environment and generating new documents.
- Experience writing FDA applications and EUA510(k).
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.