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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, San Jose , Regulatory Affairs Specialist, Other , Sunnyvale, CA, California


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