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Knowledge of OSHA, FDA, and HIPAA compliance. Performing/administering trigger point injections, joint injections, and occipital nerve block with or without ultrasound guidance. Job Summary: We are a leader in interventional pain management across Arizona with a mission to provide effective and innovative pain management solutions to all of our patients.
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Provide legal guidance and support on a wide range of regulatory and medical affairs matters, including but not limited to pre-market approvals, submissions and responses to the FDA, quality systems, commercialization, advertising, promotions, marketing, communications and labeling for on-label and off label products, new product introductions and revenue models, post-surveillance, inspections, deficiency/warning letters and/or recalls.
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Highly experienced with FDA, EU, and CMC regulatory submissions. Offer scientific, strategic, and practical guidance across the entire spectrum of pharmaceutical drug product development, covering pre-formulation, formulation development, non-clinical and clinical manufacturing, and preparations for commercialization.
$220,000 - $260,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Join Takeda as a Director, Precision Medicine and Digital Health where you will be responsible for providing strategic guidance and oversight for the delivery of global regulatory strategies to support the development of biomarkers, diagnostic tests, devices, and digital health tools to enhance the value of our products across therapeutic areas.
$165,200 - $236,000 a yearFull-timeExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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Research FDA, CMDR, MDR, IVDR and UK MDR2002 guidance documents for regulatory requirements. Review labeling, package inserts, ad materials and company website to meet FDA and CE regulatory requirements.
$90 - $120 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Work with various importing requirements such as FDA, EPA, AD/CVD, Section 201,301,232, quotas and Free Trade Agreements. As a member of the Client customs team, the individual will provide guidance relating to US Customs processes, as well as facilitate transactional support for US imports and exports.
ExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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A Minimum of with 6+ years Biotech/Pharmaceutical experience or equivalent industry experience Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
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Medical Device, Regulatory Affairs, FDA, 510K, IDE, PMA. Medical Device,Regulatory Affairs,FDA. Conduct research on applicable product standards and guidance documents issued by health authorities worldwide and determine impact of proposed and current global regulations to propose suggestions for expediting approvals.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Represent Quality Engineering when collaborating with designated personnel to develop various Computer Systems Validation (CSV) documents per FDA guidance (General Principles of Software Validation), including but not limited to Requirements Specifications, Validation/Test Plan, Testing, Integration Test Scripts, Operational/System Test Scripts, Validation Summary Reports.
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Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
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Ongoing tracking and evaluation of legal and regulatory developments at the Federal and state levels pertinent to the commercialization of innovative pharmaceuticals, including but not limited to guidance and advisories from FDA, OIG, DOJ, CMS, and other relevant government agencies.
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Ensures compliance with FDA and other relevant regulatory requirements and standards Ensure department personnel are aware of Fresenius Kabi's Environmental and Energy Management System including Environmental and Energy Policy.
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Identify new research opportunities beyond the OpCo or Platform core R&D efforts and support strategic IP management, as well as guidance around FDA and international regulatory matters, partnering with Platform and OpCo legal counsel.
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Individual must have prior project regulatory leadership experience with specific focus on the CMC aspects for small molecules, large molecules and/or cell/gene therapies, including detailed knowledge of FDA and EMA regulations and guidance for drug development, preparation and management of IND/CTA/MAA/NDA/BLA. Prior experience with preparation and preferably, negotiation to marketing approval in major markets is desirable.
$167,000 - $241,925 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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PhD or PharmD with 4-6 years of related industry experience; or, FDA or MS degree with 7-10 years industry experience; or, BS degree with 12 years industry experience, including 2 + years of local regulatory experience.
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