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27 days old

Regulatory Affairs Specialist

Kelly Services
Fremont, CA 94536
Calling all California based Regulatory Affairs SME's - I have a great opportunity for you which can be remote for the right candidate, although preference is to find somebody local.


+ Job Title: Regulatory Affairs Specialist

+ Location: Fremont, CA

+ Duration: 6 months

+ Rate: $45-55/hr.


**Job Description:**

The Regulatory Affairs Specialist will join existing team and provide support for International Registration of IVD products.


Tasks will include:

Initiation, collection, and coordination of information of regulatory documents for various purposes.

Preparation and maintenance of product technical files for CE marking. Experience of EU IVDR or MDR a plus.

Organization and preparation of documents for international submissions, including drafting reports, and preparing documentation for submissions

Coordination with international counterparts to obtain product approvals and renewals.

Maintaining logs and trackers.

Organize, update, and maintain regulatory documentation in accordance with department and company procedures.


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


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-08-27 Expires: 2021-09-27

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Regulatory Affairs Specialist

Kelly Services
Fremont, CA 94536

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