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We have an exciting opportunity on our Therasphere R&D team for a Principal Software Engineer/ Architect to lead digital product development efforts, working in partnership with Marketing, Program Management, IT, Sales, Legal, Regulatory, and other internal stakeholders to shape franchise software strategy focused on enhancing customer experience.
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Key activities for the director include setting strategic direction for the global downstream and upstream business, meeting global revenue and profitability targets, building a high-performing marketing team and working cross functionally to integrate strategies with the quality, legal, regulatory, operations, clinical, medical affairs, reimbursement, regional marketing and regional sales teams.
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Regulatory affairs certification (RAC) or relevant professional certification (e.g., ASQ Certified Quality Auditor) preferred but not required. Collaborate with cross-functional teams, including manufacturing, quality assurance, quality control, regulatory affairs, and supply chain, to address GMP-related issues and drive continuous improvement initiatives.
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Must have strong working knowledge in environmental regulatory compliance related to fire, safety, OSHA.A minimum of three years management experience, specifically in managing two or more staff, managing at a department or supervisor level, direct budget responsibilities, managing oversight of more than one trade discipline, project management responsibilities.
$88,275Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Support projects or other initiatives from cross-functional groups and departments (i.e., Project Management teams, Scientific group, Quality/Compliance, Data Management, Biostatistics and Regulatory Affairs), and ensure adequate safety support and timely update of safety information to internal and external stakeholders.
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The Regulatory Affairs Specialist will develop strategies and submissions for projects and issues related to regulatory documents, global submissions, investigations, product development planning, and regulatory agency interaction for blood products and biologics.
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Our Maple Grove office has an immediate opening for an Environmental Scientist working at the cutting edge of wetlands, regulatory and permitting, and water quality. Regulatory experience pertaining to local, state, and federal permitting and NEPA compliance.
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Monitoring compliance with internal audit and security and emergency policies, procedures and training as well as local, state, and federal regulatory requirements; monitor and coordinate compliance with district standards for security and emergency management, emergency planning, crisis preparedness, and advising the Assistant Director of Security and Emergency Management regarding identified gaps in compliance and security and emergency vulnerabilities.
$78,150 a yearFull-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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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.
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Experience in at least one of the areas: leadership, planning, enrollment management, student affairs program development and evaluation, staffing, budget management, and supervision. This position will serve as a member of the aligned President's Cabinet and the Dean's Council and Student Affairs Leadership Team (SALT) at Anoka Technical College.
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Develop, influence, and nurture trust-based relationships with government officials at city, county, state, and federal levels and act as district representative to these entities in collaboration with the Director of Transportation and Security and Emergency Management Operations and the Assistant Director of Security and Emergency Management.
$78,150 a yearFull-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g., ISO, MDD/MDR). In this exciting role as Senior Statistician, you will be responsible for statistical aspects of study design and analysis of data from clinical studies conducted for regulatory approval or marketing purposes.
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Ensures compliance with regulatory operations such as Change controls, quarterly SOX/PCI sign offs, RCTS, Privacy activities as agreed with IT and business and participates in relevant governance meetings (DPC, CAB, process reviews.
$165,750 a yearExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Job Title: MDR - Principal Regulatory Affairs Specialist. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
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The Manager works collaboratively in partnership with Clinical and Regulatory Affairs to advance Shockwave Medical products. The Manager interacts with external statistical experts, regulatory and global health authorities and oversees the work of contract research organization (CRO) Biostatistics vendors.
$191,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago
regulatory affairs jobs Title: regulatory affairs manager in Coon Rapids, MN
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