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Principal Regulatory Affairs Specialist

Location
Dublin, OH

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nnJob DescriptionnWhat Reg Affairs (FDA & EU)  contributes to **MEMBERS ONLY**SIGN UP NOW***.rnRegulatory Affairs (FDA & EU) is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval. This position will be responsible for preparation, submission and maintenance of domestic and international regulatory applications and filings including 510(k)s, Technical Files, Summary Technical Documents and Design Dossier submissions.rnQualificationsBachelors in related field, or equivalent work experience, required4 years experience in Regulatory Affairs in FDA regulated industry, requiredExperience submitting FDA/EU regulatory standards (510K, Design Dossier, Technical Documents), required Regulatory Affairs Certification (RAC), preferred Working knowledge of ISO 13485 / 14971, preferred rnWhat is expected of you and others at this levelApplies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projectsMay contribute to the development of policies and proceduresWorks on complex projects of large scopeDevelops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectivesCompletes work independently receives general guidance on new projectsWork reviewed for purpose of meeting objectivesMay act as a mentor to less experienced colleaguesrn**MEMBERS ONLY**SIGN UP NOW***. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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