13 days old

Associate Regulatory Affairs Specialist III

Kelly Services
Alpharetta, GA 30009
**We are seeking an Associate Regulatory Affairs Specialist III for a 6 month assignment in Alpharetta, GA.**

Description/Comment: Support regulatory compliance throughout the organization by performing the required activities that assure compliance with domestic and international regulations. Help refine and maintain systems for organizing and retrieving regulatory related information.

Responsibilities fundamental job duties :

1. Maintain regulatory affairs files e.g. scan, print, file

2. Research, renew and obtain State Licensing where needed for the I-Flow facility.

3. Support and participate in audits performed by internal and external e.g., FDA, Notified Body, etc representatives.

4. Support the implementation of regulatory activities throughout the I-Flow facility.

5. Assist in preparation and execution of Field Action activities.

6. Provide regulatory support for International Registrations, DMRs, Technical files, Design Dossiers, etc.

7. Support MDR Analyst with Medical Device Reporting MDRs and Medical Vigilance Reporting MDVs .


Regulatory experience with 510K, Technical Files and STED. The minimum requirements are: At least 1 yr. regulatory affairs experience. Experience writing STED or technical files preferred. Knowledge of EU MDR preferred.


**For immediate consideration please send your resume in a WORD document to**

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at


Posted: 2020-01-06 Expires: 2020-02-06

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Associate Regulatory Affairs Specialist III

Kelly Services
Alpharetta, GA 30009

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