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Regulatory Affairs/ Quality Assurance SpecialistXoran Technologies - Ann Arbor, MIResponsibility ? Plan, organize and implement strategies and activities required to procure regulatory approval for current and new product lines. ? Ensure compliance to all US and international requirements and corporate policies and procedures regarding submissions and other requirements for market approval of medical devices/combination products. ? Assist department Managers with the development, implementation and maintenance of regulatory SOP's ? Interface and coordinate with the FDA and other regulatory agencies on submissions, approvals or other issues. ? Interpret and communicate existing and/or new regulatory requirements as they relate to company products and procedures. ? Develop content and format for regulatory submissions and related supplements and amendments. ? Advise...originally from Regulatory Affairs Professionals Society - More Tools...
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Xoran Technologies
Designs & Mfg Medical Imaging Devices
| Company Type | Private |
| Company Revenue | Less than $5M |
| Company Size | 10 - 100 employees |
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