Regulatory Affairs Specialist
Company: Cepheid
Location: Sunnyvale, CA
Posted on: March 2, 2018
Job Description:
Will prepare the regulatory submissions and interacting with
regulatory agencies and health authorities to obtain and maintain product
approvals with a focus on China and Taiwan. Will collaborate and
coordinate with distributors and marketing managers to assure international
regulatory submission plans are communicated and executed per regulatory
and business requirements. Will collect and generate technical, quality,
manufacturing, and regulatory data, reports and dossiers for foreign
regulatory submissions. Will complete the preparation and application of
regulatory submissions pertaining to product clearance/approvals by
international regulatory agencies. Will compile and provide required
legalization documents and deliverables to the local registration
representative and receive licenses for filing and tracking to renewal. Will
organize and prepare responses to deficiency letters or requests for
additional information form competent authorities. Will monitor product
licensure and approval in international markets and plan license renewals in
advance of expiration. Will generate and manage Global Trade Item Number
(GTIN) for the company’s products. Will create and update product
classification for global markets. Education and Experience: Master’s degree (or foreign education equivalent) in Chemistry,
Biology, Microbiology, Medical Technology or related field and three (3)
years of experience ensuring compliance by communicating regulatory
requirements in the life science, healthcare, or diagnostics industry;
interpreting and applying ISO guidelines (ISO13485 and ISO 9001) and standards,
US FDA 21 CFR Part 820 - Quality System Regulation, and ICH Q7 guidelines;
managing change controls and risk mitigation activities; interpreting and
compiling in cGMP/Quality Systems requirements; preparing, generating and
approving Non-Conformance/CAPA Reports; and preparing internal audits and
responding to external audits. OR Bachelor’s degree (or foreign education equivalent) in
Chemistry, Biology, Microbiology, Medical Technology or related field and five (5)
years of progressive experience as stated above. Special Requirements: Fluency in written simplified and traditional Chinese and spoken
Mandarin required. Approximately 10% -20% travel required. Interested candidates should email resumes -- with reference to
the job title -- to hr.info@cepheid.com.
Keywords: Cepheid, Pittsburg , Regulatory Affairs Specialist, Other , Sunnyvale, CA, California