Job Description

Regulatory Compliance Engineer

6 month contract assignment with conversion

Monday -  Friday 40/hrs

Job responsibilities:

        Work to IEC/EN safety standards to obtain and retain CE compliance of selected Medical/Industrial devices

        Work with 21CFR FDA standards as required

        Review and assemble documentation to create and maintain technical construction files for our client’s medical equipment and devices

        Generate risk management profiles as required for each device submission

        Generate Essential Requirements lists in accordance with IEC/EN standards

        Generate FMEA and Fault Tree Analysis

        Research substantially equivalent devices as necessary

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

        Compose proposed test plans that may be required

        Compose Validation and Verification documentation

        Compose new and related Work Instructions and Control Forms in accordance with Quality Performance requirements

        Prepare documentation for FDA 510(k) submissions

        Prepare documentation for CE compliance submission (Technical Construction File)

Position works in conjunction with:

- Quality Control Department
-           - Engineering Department

-  Outside vendor test facilities for 3rd party product testing

 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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