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Equivalent work consisting of at least eight (8) years of experience working in the research regulatory field in a clinical research or scientific setting, an institutional review board office, research administration, or regulatory affairs in a pharmaceutical and/or medical device company.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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The purpose of the Medical Device Safety Scientist Associate Director role is to leverage clinical and scientific expertise working across Lilly's device product portfolio to lead the completion of safety signal detection and clarification, preparation of device safety reviews, support for regulatory inquiries, input into device development and risk management activities, and the promotion and advancement of Global Patient Safety's capabilities in the field of device safety.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio.
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Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand and portfolio team review committees (RC), providing regulatory input into the review and approval of US advertising, promotion, disease-state, market access, and press materials.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Solid understanding of clinical trial processes and regulatory affairs. Responsibilities include study start-up, device shipment management, and maintaining the Trial Master File.
ExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Proclinical is seeking a Senior Regulatory Affairs Associate or a Regulatory Affairs Consultant with a strong background in CMC post-approval. Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Working knowledge of CFR, ICH-GCP, Clinical and Regulatory Affairs. Experience in conducting medical device studies and/or in-vitro diagnostics studies preferred. Participate in the interim and final reviews of study data in preparation of regulatory submissions.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Consultant Regulatory CMC - Permanent - Boston, MA. Update HA question record in Vault and coordinate dispatch of information to Affiliate noting status changes in Veeva. CMC Vaccines authoring experience is preferred, but consideration will be given to those with strong CMC Biologics authoring experience.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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The Associate Director Regulatory Affairs, In Vitro Diagnostics and Companion Diagnostics works with internal and external partners to develop and implement global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives.
RemoteExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Associate Director Regulatory Affairs – Vascular (on-site) page is loaded. Associate Director Regulatory Affairs – Vascular (on-site) As a manager, the function of an Associate Director Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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At Tempus, we are building a regulatory team that will adopt creative approaches as we develop regulated medical devices and seek marketing authorization from FDA. Our Senior Manager/Associate Director of Regulatory Affairs will work closely with our scientists, engineers, clinicians, quality professionals, and legal team to support our efforts to advance personalized medicine.
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Regulatory Affairs Associate. 1-2 years of hands-on experience in regulatory affairs, preferably in a medical device or related industry. Join our dynamic team as a Regulatory Affairs Specialist, where you will play a pivotal role in ensuring compliance with various regulatory requirements across different jurisdictions.
$65,000 - $80,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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We're looking for an Associate Director Regulatory Affairs CMC , working in Pharmaceuticals and Medical Products industry in Cambridge, Massachusetts, United States. Minimum 8 years of experience in the pharmaceutical/biotechnology/life science industry, including at least 5 years regulatory affairs experience including managing submissions and developing regulatory CMC strategy for development and/or commercial pharmaceutical or biological products.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Knowledge of regulatory affairs for FDA (or international equivalent) registered medical device or pharmaceutical manufacturer and direct experience with conducting or participating in FDA (or international equivalent) or supplier audits.
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FDA, Regulatory Affairs, Pharmaceutical, Medical Device, GCP, GMP, GLP, Quality Assurance, Documentation, Regulatory Submission. BS Degree (Preferred) ~2 years of Regulatory Affairs or related experience in the FDA environment.
ExpandApply NowActive JobUpdated 1 month ago
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