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  1. Compliance/Audit Specialist - 993

    Minimum Education: Bachelor’s Degree Minimum Years Experience: 1 year of experience in medical device or other regulated industry Preferred Years Experience: 2 years of experience   Position Description: Provides administrative and project support to the Regulatory Affairs team located in Santa Ana, and remotely in Mounds View, MN. They will independently perform complex and diverse administrative duties, as well as project submission support.   Position Responsibilities: • Maintain electronic ...

  2. Regulatory Affairs Manager - 510(k) Submissions

     Summary: This position is responsible for regulatory submissions to the FDA, state and federal EPA, and Health Canada device and drug submissions as necessary. Essential Duties and Responsibilities: include the following. Other duties may be assigned. · Advises business units regarding the development and implementation of regulatory strategy, potential areas of regulatory concern, and new government/regulatory developments. · Responsible for the submission of FDA 510k submissions, pre-IDEs, State ...

  3. Sr. Product Development Engineer

    Mattson Resources, a premier medical device search firm seeks a highly successful engineer for a Senior Product Development Engineer.   Job Profile:           This position provides the leadership and technical expertise for designing, developing medical disposable products undergoing design or manufacturing process changes.           Projects to include converting concept models and customer requirements into highly reliable, manufacturing ready, and profitable products that consistently meet ...