Vacancy expired!
Job Description
Senior Regulatory Affairs Specialist Irvine, CA 6+ month contract to hire DOE Immediate hire with growing company. The Senior Regulatory Affairs Specialist will draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality and well supported by literature and regulatory foundations, are presented in a manner to facilitate review, and are in conformance with appropriate statutes, regulations, and guidelines . Required Skills:- Must have 4+ years experience in US and EU MDR medical devices
- Must be able to author CE Technical Files under EU MDR.
- Must be competent in auditing, risk management, familiarity with biological assessments
- Must have experience with Post Market Clinical follow up, labeling requirements.
- Must have familiarity with QSR (21CFR820) and ISO13485 or similar regulated industry (eg AS9100, ISO9001, etc).
- Must be willing to work 100% onsite
Vacancy expired!