Kelly Services Regulatory Affairs Specialist in Santa Ana, California
Kelly Services’ Outsourcing & Consulting Group is urgently seeking two Regulatory Affairs Specialists in the Santa Ana area for a six-month assignment with possibility of extension. This is full time/40 hours per week and comes with enhanced benefits.
The Regulatory Affairs Specialist will:
Coordinate, compile, and supply regulatory documents to regulatory teams in Latin America, Asia Pacific and Europe, Middle East and Africa.
Work with regulatory management to ensure rapid and timely approval of new products and renewals.
Provide Regulatory support to project teams, create detailed Regulatory Plans/strategies and in-depth team involvement, including Core Team membership for complex projects.
Evaluate proposed product modifications for Regulatory impact on a world-wide basis.
Complete Regulatory Assessments as needed.
Work under minimal supervision, with benefit of previous regulatory experience.
Requires a general use and application of Regulatory concepts, practices and techniques.
Develop solutions to a variety of problems of moderate scope and complexity.
Participate in the development, review and approval of product labeling.
Perform other duties as assigned by the manager of this position.
A Bachelor’s Degree and a minimum of 2 years regulatory affairs work experience is required .
Knowledge of European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) is preferred.
Experience with Quality Management System Standard ISO 13485 is preferred.
Knowledge of International Medical Device requirements (China, Japan, Canada, Australia, Brazil, Russia, etc.) is preferred.
Excellent written and oral communication skills are required .
Good analytical thinking, organization, problem solving, and investigative skills are required .
Proficiency in Microsoft Office and all related applications is required .
If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!
This position comes with enhanced benefits which include:
50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*
Paid sick days and vacation days*
Perks of being a Kelly employee:
Weekly electronic pay
Access to more than 3,000 online training courses though Kelly Learning center
Online application system
Never an applicant fee
*benefits to be received upon meeting eligibility requirements
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at firstname.lastname@example.org.
Why Kelly ® ?
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ® ) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm