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Serves as the go-to AAA - The Auto Club Group (ACG) public affairs representative within ACG territory in Minnesota by supporting Insurance, Membership, and Travel business lines through community event planning and organization, as the primary regional spokesperson and subject matter expert in the media, and in partnership with key regional stakeholders (law enforcement agencies, governmental agencies, schools, community service and safety organizations) and field management.
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Demonstrate data analysis skills and sound statistical analysis methodologies to prepare data for regulatory review (Minitab, JMP or MedStat). This person will work with other engineers and contract manufacturers to achieve project milestones including, but not limited to, design verification testing, regulatory submission and product launch of initial concepts and future iterations of the product.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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We have an exciting opportunity on our Therasphere R&D team for a Principal Software Engineer- Full Stack Web Applications Development to work in partnership with Marketing, Program Management, IT, Sales, Legal, Regulatory, and other internal stakeholders to shape franchise software strategy and lead digital product development efforts focused on enhancing customer experience.
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Follows documented design processes to meet regulatory and company requirements. Ability to use structural finite element analysis software such as Cosmos or Ansys. The Principal Mechanical Engineer will be responsible for the mechanical design, development, and testing of a transcatheter heart valve and related accessory components for the treatment of aortic stenosis.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Familiarity with inventory control, OSHA, HACCP and other regulatory requirements. Regularly inspect facility for safety hazards and either resolve them or report them to the safety manager as appropriate.
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As a member of the Commissioner's Office team, the Director of Tribal Affairs will work with agency Assistant Commissioners, Communications, Government Relations, Community Affairs, policy and legal teams, and Division Directors to build Tribal affairs strategies that can grow relationships and help further agency initiatives.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Support clinical activities to stay in compliance with the study Monitoring Plan requirements and compliance to Protocol, applicable regulatory standards, IRB policies and procedures. Support development of study essential document templates (e.g., study guides, study tools/worksheets) and ensure Trial Master File (TMF), Sponsor Site Files (SSF), and Investigator Site Files (ISF) are maintained and kept up to date; assist in audit readiness and preparation.
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The EHS Manager will be responsible for developing, recommending and implementing EHS policies and procedures across Walman to ensure compliance to all applicable local, state & Federal regulatory requirements.
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Supports Regulatory Affairs and other departments by providing technical input on sterilization, and microbiology related content of regulatory submissions and departmental procedures.
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Adheres to Integer Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
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The role reports to the Senior Manager IT Quality and is within the IT Quality & Regulatory Assurance organization. Drives the GXP Inspection Support and defends the validation strategies to internal auditors, regulatory authorities, and other certified bodies.
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Experience in clinical research and regulatory affairs, specially related to the launch of high complex technology in US and OUS. The Clinical Leader will provide integrated, strategic clinical research & medical science input to the OU Leadership Team and serve as a clinical resource for navigating through the complexities of the regulatory approval process and post-market surveillance, e.g. well-versed in the requirements of the European Medical Device Directive and US FDA PMA and 510(k) processes.
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Leveraging your strong technical background in chemistry, chemical engineering, and/or environmental engineering and with a proven track record in designing and implementing water purification systems using the latest technologies, you will work closely with cross-functional teams to deliver innovative solutions that exceed expectations and ensure compliance with regulatory standards.
$136,000 - $187,000 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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With adequate supervision, the Regulatory Affairs Specialist III is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations.
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regulatory affairs jobs Title: regulatory affairs manager Company: Jobget in Anoka, MN
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