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Senior Regulatory Affairs Specialist
1 week ago
Lead the development of on-product labeling; advise and approve advertising and promotional materials in accordance with regulations and device-specific regulatory clearances/approvals.
Prepare regulatory documentation for international product registration, including EU technical files and Certifications to Foreign Governments and Certificates for Export.
Interpret regulations and provide regulatory guidance to global teams. Bachelor's degree in engineering, scientific discipline, regulatory affairs or related field. (U.S. or foreign equivalent).2 years' experience in a Regulatory Affairs role for a medical device company working with US FDA regulations and Quality System regulations and Medical Device Regulation (EU) 2017/745.
Employer performs drug testing/screening, reference and background checks, education verification and employment verification. Resumes torecblid 7jtoe4tpqdhje30sd7jvwlunshlsbj
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Senior Regulatory Affairs Specialist
1 week ago
Durham, North Carolina, United States Bioventus Full timeSenior Regulatory Affairs Specialist page is loaded Senior Regulatory Affairs Specialist Apply locations Durham, NC time type Full time posted on Posted 4 Days Ago job requisition id R Are you ready to work for a more active world? At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our...
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Manager, Regulatory Affairs Labeling
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Durham, North Carolina, United States HUMACYTE GLOBAL INC Full timeJob Description Job Description Manager, Regulatory Affairs LabelingPosition Profile Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham,...
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Associate Director, Regulatory Affairs
1 week ago
Durham, North Carolina, United States The Ladders Full timeAbout the position: The Director / Associate Director of Regulatory Affairs will be responsible for contributing to the development and overseeing the implementation of global regulatory strategies for assigned programs in alignment and in compliance with local and regional requirements, and company policies. In addition, it will be necessary for the person...
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Associate Director, Regulatory Affairs
1 week ago
Durham, North Carolina, United States Shattuck Labs, Inc. Full timeAbout the position:The Director / Associate Director of Regulatory Affairs will be responsible for contributing to the development and overseeing the implementation of global regulatory strategies for assigned programs in alignment and in compliance with local and regional requirements, and company policies. In addition, it will be necessary for the person...
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Durham, North Carolina, United States GlaxoSmithKline, plc Full timeAre you interested in a highly visible, global role that allows you to lead a team of regulatory experts while being part of the CMC regulatory leadership team to contribute to the advancement of a robust and innovative product pipeline? If so, this Regulatory Affairs, Director, Regulatory, Product Owner, Business Services, Business
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Durham, North Carolina, United States GlaxoSmithKline Full timeSite Name: USA - North Carolina - Research Triangle Park, Bangalore, India - Maharashtra - Mumbai, Poznan Grunwaldzka, UK - London - BrentfordPosted Date: Apr Are you interested in a highly visible, global role that allows you to lead a team of regulatory experts while being part of the CMC regulatory leadership team to contribute to the advancement of a...
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Durham, North Carolina, United States GlaxoSmithKline Full timeSite Name: USA - North Carolina - Research Triangle Park, Bangalore, India - Maharashtra - Mumbai, Poznan Grunwaldzka, UK - London - BrentfordPosted Date: Apr Are you interested in a highly visible, global role that allows you to lead a team of regulatory experts while being part of the CMC regulatory leadership team to contribute to the advancement of a...
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Durham, North Carolina, United States GlaxoSmithKline Full timeSite Name: USA - Pennsylvania - Upper Providence, GSK House, Switzerland - Zug, USA - Massachusetts - Waltham, USA - North Carolina - DurhamPosted Date: May Purpose Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting...
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Durham, North Carolina, United States GlaxoSmithKline Full timeSite Name: USA - Pennsylvania - Upper Providence, GSK House, Switzerland - Zug, USA - Massachusetts - Waltham, USA - North Carolina - DurhamPosted Date: May Purpose Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting...
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Senior Specialist Q. A
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Durham, North Carolina, United States Integrated Resources, Inc Full timeJob DescriptionJob DescriptionJob Title: Senior Specialist Q. A - Level IJob Location: Durham, NCJob Duration: 12+ monthsJob Description: BelowRoles and Responsibilities:Responsible for environmental monitoring in aseptic environment, collection and processing of water samples, component and product release testing. Qualifications/ Requirements:Quality...
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Regulatory Risk Manager
1 week ago
Durham, North Carolina, United States BASF Corporation Full time**Now Hiring Regulatory Risk Manager** Research Triangle Park, NC **The world needs creative solutions. We need YOU** **Where the chemistry happens** We are looking for a Regulatory Risk Manager to be responsible to lead the development of risk mitigation strategies across the portfolio. In this role you will consult regulatory affairs managers, marketing...
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Associate Dean, Development and Alumni Affairs
11 hours ago
Durham, North Carolina, United States Duke University Full timeAssociate Dean for Development and Alumni AffairsA diverse community of scholars, scientists, educators, andclinicians, Duke UniversitySchool of Nursing (DUSON) is educating the next generation oftransformational leaders in nursing. The school advances nursingscience and education around the globe and fosters the scholarlypractice of nursing across the U.S....
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US Medical Affairs Lead, Immunology
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Durham, North Carolina, United States GlaxoSmithKline Full timeSite Name: USA - Pennsylvania - Upper Providence, Durham Blackwell Street, Philadelphia Walnut StreetPosted Date: Jun 3 2024About the RoleThe US Medical Affairs Lead for Benlysta is the US Medical Affairs leadership team member accountable for overall medical strategy and achievement of the tactical objectives for the asset. This leader is responsible for...
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Vice President, Medical Affairs
2 months ago
Durham, North Carolina, United States ACHC Full timeVice President, Medical Affairs & Community Care ServicesAre you a dynamic trailblazer looking to apply your medical expertise to assisting our rapidly growing company in improving patient care? The Vice President, Medical Affairs & Community Care Services will lead our Community Care Services division and be responsible for overseeing the operations of...
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Vice President, Medical Affairs
3 weeks ago
Durham, North Carolina, United States ACHC Full timeVice President, Medical Affairs & Community Care ServicesAre you a dynamic trailblazer looking to apply your medical expertise to assisting our rapidly growing company in improving patient care? The Vice President, Medical Affairs & Community Care Services will lead our Community Care Services division and be responsible for overseeing the operations of...
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Senior Specialist, Manufacturing Automation
1 month ago
Durham, North Carolina, United States Merck Full timeJob DescriptionPosition Description:Senior Specialist, Manufacturing AutomationThe Senior Specialist Manufacturing Automation person is primarily responsible for supporting qualification of Fermentation Process Automation at our Company's Durham, NC facility. Responsibilities include: supporting commissioning and qualification efforts, troubleshooting...
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Senior Specialist, Manufacturing Automation
3 weeks ago
Durham, North Carolina, United States Merck Full timeJob DescriptionPosition Description:Senior Specialist, Manufacturing AutomationThe Senior Specialist Manufacturing Automation person is primarily responsible for supporting qualification of Fermentation Process Automation at our Company's Durham, NC facility. Responsibilities include: supporting commissioning and qualification efforts, troubleshooting...
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Senior Information Technology Specialist
1 week ago
Durham, North Carolina, United States Arthur Lawrence Full timeArthur Lawrence is looking to hire a Senior Information Technology Specialist for one of our clients in Durham, NC. Please find the job description below and send us your updated resume, if interested: Must-Have: 10+ years of experience as a Senior Information Technology Specialist Experienced with project/program management, Server Integration, and...
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Senior Specialist, Quality Control
1 month ago
Durham, North Carolina, United States Merck Full timeJob DescriptionThe Quality Control Senior Specialist plays a critical role in ensuring the quality of our products by managing laboratory data and overseeing the review of microbiological, chemical, and analytical data. This role requires close collaboration with various teams including Production, Quality Assurance, Validation and Facilities, as well as...
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Senior Specialist, Quality Control
1 week ago
Durham, North Carolina, United States Merck Full timeJob DescriptionThe Quality Control Senior Specialist plays a critical role in ensuring the quality of our products by managing laboratory data and overseeing the review of microbiological, chemical, and analytical data. This role requires close collaboration with various teams including Production, Quality Assurance, Validation and Facilities, as well as...