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Coloplast Corp. Senior Regulatory Affairs Specialist Minneapolis , Minnesota Apply Now Senior Regulatory Affairs Specialist Location: Minneapolis, MN, US Job Family: Country/Region: United States The Senior Regulatory Affairs Specialist is responsible for complaint assessment and complaint reporting.
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Position Summary:The Advanced Regulatory Affairs Specialist provides independent support to senior regulatory staff to submit regulatory filings. Compile, analyze and draft reports, SOPs and regulatory filings as assigned.
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The Quality Assurance Specialist is based in a Kerecis office and reports to the VP of Regulatory Affairs and Quality Assurance. The Quality Assurance Specialist supports the project teams during the development process of new products and supports existing products when necessary.
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4+ years of experience in medical device regulatory affairs with roles showing increasing responsibility. Act as Regulatory Affairs representative on project transfer teams.
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Additional training in regulatory affairs, quality assurance, project management, risk management, etc. Assist with the development of effective long and short-term Regulatory product strategies by closely working with global Sales/Marketing and Product Development teams on pipeline medical device and drug international registrations.
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Master's degree in Regulatory Affairs, Biomedical Engineering, Chemistry, or closely related field and 2 years' experience as a Regulatory Affairs Specialist, R&D Engineer or related occupation; OR Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Chemistry, or closely related field and 5 years' experience as a Regulatory Affairs Specialist, R&D Engineer or related occupation.
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The Regulatory Affairs Specialist will support international registrations and renewals. Laborie Medical Technologies is currently searching for a Senior Regulatory Affairs Specialist to join our team.
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Regulatory Affairs oversees compliance activities for customers. Currently have or pursuing a Master in Regulatory Affairs. Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in USA, Canada and Europe.
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Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN. In this role, you will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications.
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Principal Regulatory Affairs Specialist, Software (U.S. Hub based) Lead project teams for end-to-end Regulatory Affairs input and deliverables for new product introductions and product changes across the globe.
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Senior Regulatory Affairs Specialist (Sr. RAS) Senior Regulatory Affairs Specialist - Peripheral Vascular Health (hybrid) Minimum 4 years of medical device experience, with work experience in regulatory affairs.
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Stay abreast of regulatory procedures and changes in the regulatory climate. Maintain and update regulatory authorizations, such as IDEs, 510(k)s, Canadian medical device licenses, and CE dossiers for EU, NRTL certifications, etc.
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The Senior Principal Regulatory Affairs Specialist will provide regulatory support for both premarket and post market projects (e.g., PMA, IDE, and Qsub applications). Providing regulatory affairs feedback and guidance to other functions Prepare regulatory submissions Negotiate and interact with regulatory bodies Manage multiple projects and prioritize tasks.
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The College of Continuing and Professional Studies (CCAPS) offers three affiliated programs – a Master of Professional Studies in Applied Sciences Leadership (ASCL) degree and graduate certificates in Leadership for Science Professionals and Regulatory Affairs for Food Professionals.
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