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Regulatory Affairs Specialist

Company: Actalent
Location: Cuyahoga Falls
Posted on: March 20, 2023

Job Description:

Description:Post Market Surveillance - Will write Post Market Surveillance Reports, Periodic Safety Reports, and Post Market Clinical Follow ups. - Will coordinate Field Safety Corrective Actions and provide reports to Regulatory Authorities (recalls). - Write Clinical Evaluation reports per regulatory requirements. - Assist in maintaining Quality Management System to ensure domestic and international standards are met.Skills:Regulatory affairs, Regulatory, Medical device, Regulatory submission, Quality assurance, Regulatory documents, MDR, MDD, Regulatory compliance, Compliance, Iso 13485, 21CFR820, raps, FdaTop Skills Details:Regulatory affairs,Regulatory,Medical device,Regulatory submission,Quality assurance,Regulatory documents,MDR,MDD,Regulatory compliance,ComplianceRequired Skills: --- Bachelor's degree in a science, mathematics, engineering or other technology field--- 3-5 years of progressive experience in regulatory affairs--- Experience with medical device products--- Proficient in Microsoft Office Suite (Word, Excel, Project, Visio, Power Point, Outlook)--- Problem solving/analysis including statistical process control--- Technical capacity including decision making, communication and reporting--- Strong interpersonal communication skill set--- Organizational skills--- Ability to handle multiple projects simultaneously--- Ability to work independentlyPreferred Skills: --- Experience working in a manufacturing environment is highly desired--- Appropriate combination of education and experience may also be acceptable--- Prior knowledge of 21CFR 820, ISO13485 and MDD/MDR QMS requirements--- RAPS or other regulatory certifications About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Cuyahoga Falls , Regulatory Affairs Specialist, Other , Cuyahoga Falls, Ohio

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