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K
Kaygen
Senior Regulatory Affairs Specialist
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Based on California data
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What they do
A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.
$105,184 / year median in California
+1% projected growth
Job Description
Senior Regulatory Affairs Specialist Kaygen Irvine, CA Job Details Contract $55 - $65 an hour 9 hours ago Qualifications FDA submissions EMDR Microsoft Excel Content creation for technical audiences Technical documentation Bachelor's degree Compliance documentation Regulatory affairs Biomedical regulatory compliance Regulatory submissions Productivity software Technical writing experience within technology Cross-functional collaboration Technical Proficiency Stakeholder relationship building Cross-functional communication FDA regulations Product lifecycle management Full Job Description Must haves: Strong attention to detail with excellent organizational, analytical, and problem-solving skills Ability to manage competing priorities in a fast-paced environment Effective communicator and collaborative team partner with strong interpersonal skills and ability to work cross-functionally Demonstrate a strong willingness to learn new processes, tools, and technologies Extensive knowledge and understanding of US FDA (Class II) and EU MDR (Class IIa/IIb/III) regulations relevant to medical devices Experience with authoring EU technical documentation, supporting notify body change notifications in coordination with cross-functional teams, compile and support 510(k) activities, and product lifecycle maintenance Ability to interact professionally with all organizational levels Follow guidance, ask questions, and training to develop role specific skills Nice to haves: Ability to build productive internal/external working relationships Coursework, seminars, and/or other formal government and/or trade association training Knowledge and understanding of global regulatory requirements relevant to medical devices Proficiency in document management systems and