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We are looking for an experienced Regulatory Affairs & Quality Assurance Lead to oversee our Mark I whole-body scanner regulatory submission and maintain market authorisation for our Gemini digital twin platform for compliance and commercial viability.
$160,000 - $200,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Familiar with regulatory standards and quality systems (e.g., GLP, GMP). Extensive hands-on experience in a wide range of analytical techniques, such as UV-Vis, HPLC, CE, SDS-PAGE, icIEF, LCMS, GCMS, enzyme kinetics, colorimetric and fluorescent plate-based assays, ELISA, Western Blot, etc.
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Our Client's FDA regulatory group works with broad range of companies, including medical devices, drugs, biologics, diagnostics, digital health, research tools, cosmetics, dietary supplements, wellness products, and other consumer products.
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Forms cross-functional alliances with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by providing SMEs to these functions and project teams.
$221,170 - $286,220 a yearExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Prior experience in healthcare and/or digital health marketing with awareness of the regulatory issues and understanding of promotional regulatory requirements. At least 3 years prior experience in search engine optimization (SEO), search engine marketing (SEM), content marketing, email marketing, digital advertising, and social media marketing.
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In addition, the Sr Director will be accountable for leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally.
$150ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Minimum of 5 years of experience as a Developer/Business Systems Analyst with a focus on QMS in the medical device industry, including expertise in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
$80 - $85 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Partner with other teams involved in the end-to-end assay launch and maintenance processes, including Clinical Ops, Clinical Lab, Quality, Regulatory Affairs, Medical, Business Stakeholders, etc.
$150Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Ensure that each group has appropriate protocols to support tech transfer including process development, QA/QC, and regulatory. Experience interacting with government regulatory agencies is a plus (FDA, DEA, etc.
$200ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The ideal candidate must have experience in securities enforcement, white-collar defense, regulatory investigations, and compliance matters. Handle securities enforcement matters, white-collar defense, regulatory investigations, and compliance issues.
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We research, develop, and commercialize innovative digital health products and solutions by bringing together the full capabilities of our team, including product strategy and management, clinical expertise, partnerships, UI/UX design, usability research, clinical research and validation, software development, AI / Gen AI, and regulatory.
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Privacy compliance strategy : Research, refine, and defend our regulatory compliance strategy; work with teams across the company to develop and implement risk mitigation plans. Transitioning to a leadership role such as General Manager, Managing Attorney, or Deputy General Counsel.
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Ideal candidates will also have some contentious practice experience, such as working on regulatory investigations and/or litigation, ideally focused on tech, data, privacy, cybersecurity or related issues, have experience with drafting and reviewing data processing agreements, privacy policies, and security policies, as well as providing day-to-day privacy advice to in-house counsel and start-up executives.
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The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum’s gene therapy program/s. The Director/Sr will be responsible for developing, executing, and advising on global Regulatory CMC strategies through all phases of Adverum’s development program/s.
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The Associate Director of Quality Control is responsible to lead all lab operations of GMP Quality Control to ensure Codexis's production operations meet regulatory standards with respect to quality, integrity and efficiency.
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regulatory job Title: sr Company: Csl Behring in Menlo Park, CA
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