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Regulatory Compliance : Ensure compliance with all relevant regulatory requirements, including FDA and EU regulations, ISO standards, and Good Clinical Practice (GCP) guidelines. Experience in designing and generating clinical documentation required per EU Medical Device Regulation, including authoring Clinical Evaluation Plans and Reports, Post Market Clinical Follow-up and driving clinical input to Post Market Surveillance Plans and Reports.
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Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
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Interface with Regulatory DepartmentEnsure compliance to all Regulations (EPA, OSHA, DEA, FDA, Health Canada, and others)Develop and Implement new procedures as required for Regulatory requirements.
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AtriCure’s Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide.
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Lead author for FDA and European regulatory submissions. + Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations. + Independently interacts and builds partnerships with competent authorities (FDA, and other regulatory agencies.
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Review and analyze production, quality control, maintenance, and operational reports to ensure compliance and determine causes of non-conformity with product specifications, customer requirements, FDA/government regulations, etc.
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Food and Drug Administration (FDA), Good Manufacturing Practices (GMP), Safe Quality Food (SQF) and Hazard Analysis Critical Control Point (HACCP) experience is highly desired. Must be approved by state badging agency to work in cannabis industry.
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The US Oncology Network , one of the nation's largest community-based cancer treatment and research networks, Compass Oncology participates in leading-edge clinical trials through US Oncology research, which has helped develop 89 FDA approved cancer therapies.
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Usually serves as the primary center physician registered as the Laboratory Director with the Food and Drug Administration (FDA). Usually serves as the primary center physician registered as the Laboratory Director with the Food and Drug Administration (FDA.
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We have acquired two FDA approved non-opioid pain products, GLOPERBA and ELYXYBTM, for the treatment of gout in adults and oral solution for the acute treatment of migraine, with or without aura, in adults.
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Investigators from the academic community, research laboratories, and industry are welcome to use the Center’s medical imaging equipment and clinical research facilities available through PET Core. The MGH PET Core is cGMP/FDA registered PET drug manufacturer that operates at cost to provide investigators with required personnel, equipment and services to design and conduct research studies using positron emission tomography.
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Familiarity with Global Regulatory Standards FDA (Food and Drug Administration), EU (European Union) GMP, USDA (United States Department of Agriculture), CFIA (Canadian Food Inspection Agency), as applicable.
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Experience working in an Operating Room, Electrophysiology (EP) Lab or Catheterization lab either through industry or clinical setting preferred, but not required. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 20 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more.
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Assures that CLIA/COLA training, CLIA/COLA proficiency testing for hematocrit and total protein, and signed of logs involving standardization takes place. Either serves as or delegates to another appropriate physician the duties of "laboratory director.
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Develop and maintain supplier-related procedures and requirements in compliance to FDA regulations, MDD, CMDR, and ISO requirements including evaluations, audits, and metrics. Assist with FDA and ISO audits.
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