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Requires Masters degree in Regulatory Affairs, Biomedical Engineering, or Medical Device Engineering, and six years of experience as a Regulatory Affairs Manager or Regulatory Affairs Specialist or related occupation in regulatory affairs, or a Bachelors degree in Regulatory Affairs, Biomedical Engineering, or Medical Device Engineering, and eight years of experience as a Regulatory Affairs Manager or Regulatory Affairs Specialist or related occupation in regulatory affairs.
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You will need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide Precision Medicine global regulatory guidance.
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The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum’s gene therapy program/s. Manage the Regulatory Affairs (CMC) Strategy for Regulatory Affairs.
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ASG is a Minority Woman Owned, Physician owned small business with over 14 years' experience in federal government contracting.
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Sr. Quality Systems Manager. Assess QMS processes for potential gaps to ensure compliance with regulatory guidelines. A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.
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Array Labs is building a distributed radar imaging constellation to power the first accurate, real-time 3D model of the world.
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We are looking for a senior indirect tax analyst to scale with our international expansion, manage indirect tax compliance and reporting, and contribute to the overall indirect tax strategy and planning.
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Practiced collaborator with demonstrated capability to partner with other business functions and internal stakeholders, comfortable within a culture of rigorous regulatory and scientific process excellence.
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The core focus areas for the Satellite Software Team include mission software (radar data collection, storage, processing, and downlink), radio communications, satellite/flight control, telemetry, and embedded firmware.
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As a Deli Associate, you guide, inspire, and make every guest's visit memorable. As a Deli Associate, no one day is ever the same. The Company operates stores across 34 states and the District of Columbia with 24 banners including Albertsons, Safeway, Vons, Jewel-Osco, Shaw's, Acme, Tom Thumb, Randalls, United Supermarkets, Pavilions, Star Market, Haggen, Carrs, Kings Food Markets and Balducci's Food Lovers Market.
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Senior Regulatory Affairs Specialist, Redwood City, CA - Develop strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate approval with global regulatory agencies.
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Reports to: Associate Director, Downstream Polysaccharide Development and Manufacturing. Vaxcyte is looking for an energetic and talented Sr. Engineer/Scientist to contribute to the Polysaccharide development and manufacturing group within the CMC team.
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Sr. Mechanical/Mechatronics Engineer. Experience with rapid prototyping (3D printing, laser cutting, machine shop skills) and manufacturing methods. Sr. Mechanical/Mechatronics Engineer. Prototype and test Mechanical and Mechatronic solutions to quantify system performance and sniff out and squash any bugs.
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Adverum is looking for an Associate Scientist with knowledge of molecular biology to join our team in our Redwood City office. Associate Scientist, Optogenetics (Contract) Hands-on experience with the execution of bioassays using technologies including qPCR, ddPCR, MSD, Luminex, flow cytometry and cell-based potency assays are advantageous.
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Senior Associate Scientist, Cell Culture Process Development - Pre-Pivotal Biologics CMC Development – Foster City, CA. The Senior Associate Scientist, Cell Culture Process Development (Pre-Pivotal) will lead and execute cell culture process development laboratory experimentation for Gilead biologics entities during pre-pivotal phases development (pre-clinical, phase I/II.
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Title: sr regulatory affairs associate Company: Thermo Fisher Scientific in Foster City, CA
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