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Regulatory Affairs Analyst
Sheboygan, WI
Job Description
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 activities to obtain and maintain or support product registration for key markets (FDA, MDSAP, Europe)Develop and lead Quality Plans to successfully maintain compliance and registrationCoordinate efforts associated with maintaining and renewing certificationsCoordinate, prepare, or review regulatory submissions for domestic or international projectsCommunicate with sales, customer service and international customersEnsure technical files are maintained as necessary to obtain and sustain product approvalSupport New Product Development teams relating to regulatory requirementsAdvise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, and/or clinical study compliance issuesDetermine the types of regulatory submissions or internal documentations that are required in situations such as proposed device changes or labeling changesCommunicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and/or clarification and follow up of submissions under reviewObtain and distribute updated information regarding domestic or international laws, guidelines, or standardsMaintain current knowledge base on existing and emerging regulations, standards, or guidance documentsIdentify relevant guidance documents, international standards, or consensus standard and provide interpretive assistanceInterpret regulatory rules or rule changes and ensure the rules and changes are communicated through corporate policies and proceduresObtain and distribute updated information regarding domestic or international laws, guidelines, or standardsAssist with Supplier Quality initiativesParticipate in internal and external auditsWrite and/or update Quality Management System procedures, standard operating procedures, work instructions, Quality Manual and policiesPerform additional responsibilities as requested to achieve business objectivesQualifications:Bachelor's degree in Biology, Chemistry, or science-related field from an accredited college or university desiredExperience with medical devices or other highly regulated industries/products desiredDemonstrated strong internal structure to successfully lead multiple activities simultaneouslyDemonstrated accuracy and thoroughnessAbility to interpret regulations and apply the regulations to the organizationStrong written and verbal communication skillsMust be able to stand, walk and/or sit for up to 8-10 hours per dayMay require occasional early morning or late evening teleconferences
Job Summary
Company
AO
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
Open
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