The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leadi...
The Associate General Counsel, Regulatory & Quality, will support a wide variety of FDA regulatory and quality matters related to the design, manufacture, distribution, and sale of Getinge medical devices worldwide, including product submissions, premarket activities, quality system regulations, man...
Solvere Technical Group is looking for a Specialist, IA Compliance. ...
Data Compliance and Monitoring Specialist. Data Compliance and Monitoring Specialist. The incumbent is responsible for monitoring and reviewing financial transactions/data on an enterprise-wide basis to prevent and detect errors and fraud and to ensure compliance with laws, regulations, policies, an...
The Senior Project Manager will be based on the construction project site and will be responsible for taking projects from conceptual stages through closeout. At Clayco, a Senior Project Manager is responsible for assisting with preconstruction, buying out contracts, and managing the project from st...
Seeking a proactive and innovative CMC Project Manager to lead the management of Chemistry, Manufacturing, and Controls (CMC) projects for small molecules and biologics, from early development through commercialization. Develop and update CMC project plans and dashboards to achieve project goals. Ov...
Develop and maintain project plans, schedules, and resource allocation to ensure timely and efficient project execution. Previous experience with leading software modernization efforts as a technical project manager. Monitor and report on project status, identifying and mitigating risks and issues a...
The work includes acting as a single point of contact for projects throughout the entire process; monitoring project costs and ensuring projects meet budget constraints; updating and ensuring the project stays on schedule and the schedule is regularly briefed with City stakeholders; ensuring that th...
A global biologics company is seeking an experienced Senior Manager/Director Regulatory Affairs to serve as the US FDA lead and play an integral role in developing and executing regulatory strategy and planning. Senior Manager/Director Regulatory Affairs. The Senior Manager/Director Regulatory Affai...
The Environmental Project Manager will manage projects focused primarily on CERCLA remedial site investigations of PFAS and chlorinated solvents, feasibility studies, proposed plans, and Record of Decisions related work. We currently have an excellent opportunity available for an Environmental Proje...
As a Senior Regulatory Affairs and/or Quality Affairs Consultant you work closely with our Head of Regulatory to support medical device (MD), in-vitro diagnostic medical devices (IVD) with a focus on software as medical device (SaMD), including AI as a medical device (AIaMD), companies to bring thei...
A vacancy exists in the Department of Aging, Senior Centers and Community Service Division. Knowledge of working with the senior adult population. ...
Collaborate with project managers, engineers, and clients to ensure transit facilities meet project objectives, are code-compliant, and exceed industry safety standards. Experience as a project manager for the delivery of projects with extensive experience in client-facing roles. As the liaison betw...
Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams. Represents the business in interactions with regulatory authori...
This is a fantastic opportunity for a Project Engineer to join our major, global pharmaceutical client on their latest new-build project based in Maryland, this is a large-scale greenfield capital project and investing more than $1bn. CAPEX Project Manager - Site & Infrastructure - Maryland - 12-Mon...
Compliance specialist will assist with collection and analysis of data relevant to compliance projects. Compliance Specialist will help the organizations ensure that their operations comply with relevant laws, regulations, and policies. Works directly with the regional leadership team to support the...
Reporting to the Director of Regulatory Affairs, responsible and accountable for developing and implementing sound strategies for complex regulatory submissions for functional unit. Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and t...
One of the most reputable Commercial General Contractors in the area is looking for a successful Project Manager to lead their projects in the northern Virginia and DC areas!! Their strong, highly skilled leadership team takes pride in their employees, treats them like family and puts in the ti...
Senior Manager Government Affairs. The position requires collaboration with other state and US government affairs team members and 3M’s government affairs team globally, as well as the company’s regulatory, legal, compliance teams as well as business and operations executives to help develop and adv...
A Professional Services Project Manager is responsible for overseeing and managing projects from inception through completion, ensuring they are completed on time, within budget, and to the client's satisfaction. Conduct project post-mortems and create recommendations reports in order to identify su...
The selected candidate will be embedded in a team of experienced project managers and professional engineers, helping to lead technical designs, coordinate with multiple discipline leads, and serve as client-forward contacts. JMT’s Southeastern PA Highway Team is in need of a strong, car...