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Regulatory Affairs Specialist
Ref No.: 18-12539
Location: santa ana, California
Start Date: 09/26/2018
Position Description
Contractor, Regulatory Affairs Specialist –
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, creates 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. Completes 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.