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...
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. Position: Sr Regulatory Affairs SpecialistLocation: Sunnyvale, CaliforniaPosition...
Regulatory Affairs Specialist II. 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 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...
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...
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 ...
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. ...
Un processus de recrutement complet pour ce poste, impliquant les RH et le Manager, nous permettra d’échanger sur la culture FRED ainsi que sur votre parcours et vos aspirations professionnelles. ...
The Associate Director / Director of Regulatory Affairs will help develop regulatory strategy and be an active partner in drug development project planning and execution. ASSOCIATE DIRECTOR / DIRECTOR OF REGULATORY AFFAIRS -. This is an individual contributor role, reporting to the Vice President, R...
You will manage tasks and associated deliverables in support of senior project managers and other leaders, alongside the wider project and client teams, to ensure the timely and accurate delivery of the project. You will deliver and manage project plans from project inception/brief, through design d...
Produce regular reports necessary for Project compliance for IRA and DOL Compliance. Quickly respond to and resolve any non-conformities identified within the project site based on guidance from Compliance Specialist. Monitor apprenticeship program metrics for a project site to ensure 100% complianc...
The Associate Construction Project Manager is responsible for assisting Senior PM’s and PM’s with the coordination of store construction projects based on the priorities and needs of the company. Partners with internal and contracted Project Managers on construction details as needed. Coordinates an...
The responsibilities of a Senior Regulatory Specialist in the energy sector will vary depending on the specific company, sector (e. Responsibilities typical of a Senior Regulatory Specialist in the energy sector are provided below. DUTIES AND RESPONSIBILITIES Regulatory Compliance - knowledge of fed...
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...
Theideal candidate will have a strong background in complianceprograms cybersecurity and clientfacing roles within a ManagedService Provider (MSP) environment. Manage compliance programs with a focuson SOC 2 and ISO 27001 frameworks. Work directlywith clients to address compliance and cybersecurityn...
We are seeking an experienced Technical Program Manager to lead our computer vision AI. Backed by a dedicated team of project managers and. Backed by a dedicated team of project managers and solution engineers, TPM delivers exceptional value through a combination of semi-automated and manual approac...
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 project manager will be responsible for supporting the International Business Development team with both new business activities and ensuring the execution of ongoing programs to completion. Work with the respective international account managers to develop positive ongoing relationships between...
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...
AMD together we advance_ PROGRAM MANAGER 2 THE ROLE: We are in search of an experienced program manager with strong analytical, problem-solving and risk management skills. PROGRAM MANAGER 2 THE ROLE: We are in search of an experienced program manager with strong analytical, problem-solving and risk ...
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....
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...
Furthermore, the Deputy Project Manager will assist in coordinating utility and local facility relocations impacted by the Authoritys project. Under the general direction of the Supervising Transportation Engineer (Sup TE), the Licensed Engineer will serve as the Deputy Project Manager. The Deputy P...
Lead Project Managers and/or Program team in the development and maintenance of comprehensive plans for a defined program. Deliver presentations of project status to effectively communicate throughout the project life-cycle. Adhere to the Organization's project management methods, project life-cycle...
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...