Kelly Services' Outsourcing & Consulting Group has an immediate opening for a Regulatory Affairs Associate in Jacksonville, FL. This is a long-term, open-ended assignment and offers benefits! Candidates must have a general use and application of domestic and global regulatory concepts, practices and techniques for medical devices.
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 for new product registrations, new product introductions, renewals, change submissions, etc.
- Work with regulatory partners to ensure rapid and timely approval of new products and renewals.
- Research, collect data, and address requests from regulatory agencies to prepare documentation required for health authority submissions.
- Monitor the external environment to help ensure compliance with new regulations, requirements, etc.
- Work under minimal supervision, with benefit of previous regulatory experience.
- Develop solutions to a variety of problems of moderate scope and complexity.
- 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.
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.About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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