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25 days old

Regulatory Data Specialist

Kelly Services
Irvine, CA 92604
We are currently recruiting for a Regulatory Affairs Specialist to support Regulatory Affairs teams and the Systems, Processes, and Analytics team. This position will be located in Irvine, CA.


The Regulatory Affairs Specialist will execute regulatory activities to support Regulatory Digital Systems for our client. This role involves a multi-faceted set of skills including cross-functional collaboration and planning/oversight/execution of projects & activities that directly impact the operational results of the business.


**Position Duties & Responsibilities**


+ Research and coordinate data collection, maintenance, and verification across the company to support the Regulatory Affairs team

+ Perform and manage data entry activities

+ Liaison between our client companies and Systems, Processes, and Analytics team to provide support and training

+ May be responsible for other Regulatory activities as needed

+ Drives a culture of continuous improvement to ensure compliance with company standards, regulatory requirements, and expectations

+ Communicates critical issues to client companies Management and Systems, Processes, and Analytics team


**Qualifications**


+ A minimum BA/BS Degree with at least 2+ years of regulated medical device industry experience (or related) required

+ Strong systems skills and comfort in information technology is required

+ Must be proficient with MS Office applications; specifically Excel and SharePoint

+ Basic working knowledge of Quality Systems and or Regulatory processes is required

+ Excellent communication, organizational, multitasking, and problem-solving skills are required.

+ Must be detail oriented, be able to work successfully within a team environment and as an individual contributor.

+ The ability to develop and maintain excellent working relationships with cross functional teams is required.

+ Ability to train internal teams and monitor system usage to ensure alignment with processes and procedures.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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)

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Posted: 2022-07-15 Expires: 2022-08-15

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Regulatory Data Specialist

Kelly Services
Irvine, CA 92604

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