Regulatory Affairs/Quality Assurance (QA) Manager Job

RA/QA MANAGER needed for a CONTRACT opportunity with Yoh's client located in Oakland, CA.

TOP SKILLS SHOULD YOU POSSESS:

- Quality Assurance or Regulatory Affairs Experience
- Experience medical device/IVD or biotechnology fields

WHAT YOU'LL BE DOING:

- Will write, review and edit regulatory documentation
- Support timely submission of regulatory documentation
- Develop, coordinate and document communications with regulatory agencies
- Manages internal document control system, including development of document templates and forms
- Perform internal quality audits and facilitate corrective actions
- Develop SOPs to cover RA/QA procedures
- As necessary, provide QA guidance to other development and/or scientific staff

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor's degree in a scientific field
- Five (5) plus years of experience in Regulatory Affairs and Quality Assurance
- Proficient in IVD technical writing
- Experience reviewing technical documentation and reports
- Proficient use of MS Word, Excel, Project, Adobe Acrobat and Visio

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Emi Flaherty

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

J2W: CLINICAL

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SFSF: HC