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Job Title: Regulatory Affairs Specialist Project Lead I. Ensure effective execution for new innovative consumer-centric products and the life cycle management of products in the portfolio across the following regulatory classes (OTC monograph drugs, dietary supplements, cosmetics, foods, and medical devices.
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A Day in the LifeAs Principal Regulatory Affairs Specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies.
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The Senior Regulatory Affairs Specialist (Sr. RAS)develops and executes strategies for global regulatory approvals working with Medtronic Geography Regulatory partners, and global regulatory agencies to introduce Mechanical Circulatory Support (MCS) product changes to market.
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Senior Regulatory Affairs Specialist - Mechanical Circulatory Support (hybrid) Minimum 2 years of experience in regulatory affairs, in the medical device industry with Master's degree.
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About Us: We are seeking a Regulatory Affairs Specialist to join our team in Irvine, CA. Our company focuses on supporting the EU's In Vitro Diagnostic Regulation (IVDR) transition activities for our biotech clients' products.
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Senior Regulatory Affairs Specialist-FDA Food 1. Have basic working knowledge of Divisional product groups and end use applications for Wacker products and provide overarching guidance and interface with Divisional and Site Quality Managers and Business Team members to ensure compliance to current and upcoming FDA regulations, International regulatory requirements and external standards including USP-NF, FCC where applicable for each site.
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We are currently seeking a Senior Staff Regulatory Affairs Specialist to join our Medical Division. As a Senior Staff Regulatory Specialist , you will be exposed to a diverse product portfolio that includes pharmaceutical, cosmetic and medical device products.
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Piper Companies is currently seeking a Regulatory Affairs Specialist, Gene & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies.
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Senior Regulatory Affairs Specialist Consultant. Senior Regulatory Affairs Specialist. Represent Regulatory Affairs and provide regulatory advice on cross-functional project teams.
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Eastridge Workforce Solutions is hiring a Regulatory Affairs Specialist for a company that offers cloud-based laboratory testing of blood tests through a central lab before releasing them to physicians for review and discussion with their patients, as well as providing consulting services.
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Bachelor’s degree in engineering (Biomedical, Chemical, Mechanical, Software/Computer, Electrical), science, or technical discipline with coursework in Regulatory Affairs/Quality Engineering - required.
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Specialized Experience: You must possess at least one (1) full year of specialized experience that equipped you with the knowledge, skills, and abilities to successfully perform the duties of a Research Study Coordinator and provided you with knowledge of the full scope of activities required in conducting single and/or multi-site clinical research including study/project management, human subjects' protection, and regulatory and policy compliance.
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2-8 years of experience in Regulatory affairs, Quality Assurance, (R&D) or Manufacturing in IVDR (Vitro Diagnostic Regulation) Regulatory Specialist (IVDR) Regulatory Affairs work in In Vitro Diagnostics (IVD) is a plus.
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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
$51,824 - $63,600 a yearFull-timeRemoteExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Stays up-to-date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings. A new research program being launched in the Department of Health & Wellness Design has a current opening for a part-time research specialist position (Principal Investigator (PI): Drew Pickett, PhD.
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