The manager will handle regulatory activities including drafting and reviewing sPMA’s, pre-submissions, and other filings. Prepare, collect, or coordinate information and prepare regulatory documentation for submission to regulatory agencies or commercial partners. Provide regulatory support to exis...
Liaise with colleagues in Regulatory Affairs therapeutics teams, company local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Senior Manager, Regulatory Affairs III. Sen...
We're currently seeking a Regulatory Affairs Director for a small, yet exciting CRO focused on IVD clinical studies. Oversee regulatory submissions, managing relationships with regulatory agencies, and guiding clients through the regulatory landscape. Lead the regulatory strategy and operations for ...
The Senior Compliance Analyst has advanced knowledge of the job area and technical systems and practices, and advanced technical skills and reporting abilities. Maintains the compliance FWA audit program, including schedules, standards, processes, reports and tools in close collaboration with Compli...
The Program Manager (PM) pro-actively leads all execution, management, and coordination of all program activities associated with assigned product delivery contracts and related growth projects during the full lifecycle of programs/projects through installation. The Leidos Security Enterprise Soluti...
We are looking for an Project Manager (hybrid) to join our client's team in Carlsbad, CA. Manage opportunities to grow project's revenues and GPs. Ensure project team adheres to QA/QC plan. Is knowledgeable in project administration. ...
The Operations Project Manager is critical to ensuring the seamless execution of the Operations strategy within Vuori. Project Management: Develop and manage project plans, timelines, and deliverables to ensure the successful execution of strategic initiatives for Operations. Reporting: Create and p...
The Quality Assurance and Regulatory Compliance Manager is responsible for product quality, manufacturing compliance, customer claims, vendor audits, safety SOPs, and continuous quality improvement process to meet higher quality standards and achieve customer expectations. This position will inspect...
The HR Compliance Manager is responsible for developing, implementing, and managing a comprehensive compliance program to ensure adherence to federal, state, and local regulations. Develop and update compliance policies, guidelines, and training programs to educate employees on compliance requiremen...
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. Regulatory Affairs Specialist II:. ...
As a Technical Program Manager (TPM), your day-to-day functions involve juggling multiple initiatives across numerous teams, stakeholder functions (Product, Design, Security, , and geographies. Driving these initiatives requires prior experience managing horizontal programs, having an operational fo...
Project management and coordination:ESA and remediation-related projectsTracking and maintaining budgets and project financesPreparing reportsMaintain client relationships in various industriesLiaise with and support other engineering disciplines. Some experience managing contaminated sites projects...
Requirements / Qualifications .Letter(s) of Recommendation (Three (3) required.Two (2) may be personal (non-relative), One (1) must be from current or past employer/supervisor....
Applies basic knowledge of compliance, business, analytical, and communication skills to support compliance programs and processes that promote compliant and ethical behavior, meet regulatory obligations, and prevent, detect, and mitigate compliance risks. This position will focus on compliance with...
Full Time – Grant Compliance Specialist I (GCS I). This role involves assisting in compliance monitoring and reporting, with supervision. Assist in the development of program policies, procedures, and compliance monitoring strategies, with supervision. Provide support on federal regulations, eligibi...
As an Associate Project Manager, you will maintain project oversight, delivery, timeline, budget, and other key components on assigned projects. Lead team meetings on a regular basis with project team to ensure project objectives are met; ensure the on-going communication to team members of the scop...
As a WendWell Health Distributor/Agency - Sales Team Manager, you will lead your team of agents dedicated to promoting and enrolling eligible customers into Affordable Care Act (ACA) healthcare plans. Conduct comprehensive training programs for new and existing agents, focusing on ACA product knowle...
From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including p...
As our Technical Project Manager on the Salesforce team, you’ll define project scope, project success criteria, and deliverables that support business goals in collaboration with senior management and stakeholders. Project Managers work closely with Stakeholders to define project objectives and over...
As a member of PointClickCare’s Legal and Compliance team, In the role of Compliance Analyst, you will be instrumental in driving key initiatives and projects that have a substantial impact on PointClickCare, its customers, and other stakeholders. Assist in the development of, and ongoing updates to...
Were seeking a skilled Cybersecurity Compliance Analyst to join our client in a remote capacity. The ideal candidate will have a strong background in compliance programs cybersecurity and clientfacing roles within a Managed Service Provider (MSP) environment. Manage compliance programs with a focus ...
Manager Trainee- Operations (Travel Program- Relocation Required). The development program lasts approximately 12 months. Upon completion, you’ll have an additional six months to advance into an Assistant Manager position. During the program, you’ll learn the business and industry, and build your sk...
Regulatory Affairs Specialist III – Global Submissions. As a Regulatory Affairs Specialist III at Thermo Fisher Scientific Inc. This is a world-class position where you will collaborate with Regulatory Project Leads to prepare flawless regulatory submissions and ensure their timely delivery to globa...
As a Senior Manager on the Environmental Compliance and Strategy (ECS) team, you will support internal teams with National Environmental Policy Act (NEPA) compliance for clean energy (e. With an increasing number of projects triggering federal environmental review, this position will serve as an int...
The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Provides regulatory guidance and defines regulatory strategy for digital products...