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Regulatory Affairs Manager

Company:
Chase Executive Search
Location:
Seattle, Washington, United States
Salary:
Up to 145, 000
Posted:
December 07, 2018

Description:

Great company with outstanding compensation package, looking for:

• BA/BS degree is required. Preferred education/experience include bioengineering, biological, physical, clinical and regulatory sciences. Previous in vitro diagnostic (IVD) nucleic acid experience and/or companion diagnostic (CDx) experience highly preferred

• 6+ years of (hands on) experience in Regulatory Affairs with FDA regulated products

• Previous experience with 510(k), IDE, and/or PMA submissions

• Working knowledge of FDA QSR and ISO 13485 regulations

• Experience in a Molecular Biology research environment

• Strong intellectual capacity and curiosity desired

• Certifications: RAC, CQA, CQM preferred

• Strong interpersonal skills with the ability to influence others in a positive and effective manner

• Strong organizational skills and ability to support multiple projects

• Proven ability to prepare regulatory submissions and interact with FDA/Health Authorities to obtain and maintain product approvals

• Proven ability to work on product development teams

• Intellectual curiosity and an ability to digest complex technical data