Regulatory Affairs Data Specialist

We are currently recruiting for a Regulatory Affairs Specialist II to support the Regulatory Affairs Systems, Processes, and Analytics team, located in Irvine, CA.

The Regulatory Affairs Specialist II will execute regulatory activities to support Regulatory 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

• Researches and coordinates data collection across the company to support the Regulatory Affairs Data Integrity Lead
• Performs and manages 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 Johnson and Johnson standards, regulatory requirements and expectations
• Communicates critical issues to Management

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
• Excellent written and oral communication skills is required
• Ability to handle multiple tasks and be detail oriented is required

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 interests—it’s 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, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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.