Job Description

Six month plus assignment.- XXX

Regulatory Specialist must have experience with ISO 13485, FDA for US and Korea compliance. International regulatory compliance experience including EU and CE Marking and licensing.  ABC 

Responsibilities:

· Prepare protocols, perform validations, generate reports, review previous corrective actions to ensure closure

· Participate with audits of processes and review audit reports and summaries

· Gathering, evaluating, organizing, managing and collating information in a variety of formats

Insure that a complete list of relevant standards documents are accessible for the affected projects (QC is responsible for acquiring standards documents)

Working knowledge of regulatory affairs ISO, FDA, Anvisa, MDSAP principles, good manufacturing practices and Quality Awareness.

· Planning, undertaking and overseeing product trials and regulatory inspections

· Keeping up to date with changes in regulatory legislation and guidelines

· Analyzing complicated information, including trial data

· Thorough knowledge of various PC, including Microsoft Word, Access, Excel and database design.

Work with 21CFR FDA standards as required

Big Plus - knowledge of 45502-1 standard (implantable) and 60601 standate (medical device/lab as it applies to electrical)

Education: Bachelor’s degree. 8 – 10 years of direct experience with regulatory affairs in manufacturing

It is the policy of GCR to provide equal opportunity to all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. GCR is an Equal Opportunity/Affirmative Action Employer and embraces diversity in our employee population. 

Application Instructions

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