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Regulatory Affairs Specialist

Employer
AO
Location
Sheboygan
Salary
Competitive

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Job Summary:Lead efforts to ensure compliance with all regulatory agencies. Support all functions relating to regulatory affairs. Coordinate activities to obtain and maintain product registrations (domestic and international).Duties & Responsibilities:Lead andsupport product registration for both domestic and international customersCoordinate efforts associated with the preparation of regulatory documents and submissionsCoordinate and prepare regulatory submissions for domestic or international projectsPrepare additional information or responses as requested by regulatory agenciesCommunicate with customer service, and international customersPrepare and maintain technical files as necessary to obtain and sustain product approvalSupport Engineering and PDS teams to successfully complete and obtain product registrationsObtain and distribute updated information regarding domestic or international laws, guidelines, or standardsCommunicate with regulatory agenciesParticipate in internal and external auditsPerform additional responsibilities as requested to achieve business objectivesQualifications:High school diploma or equivalent required; relevant Associate Degree desiredExperience working in a regulated industry desiredDemonstrated strong internal structure to successfully lead multiple activities simultaneouslyDemonstrated accuracy and thoroughnessAbility to interpret regulations and apply the regulations to the organizationProficient with the Microsoft Office Suite, especially ExcelStrong written and verbal communication skills

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