Senior Regulatory Affairs Specialist. Responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, preparing US and EU submissions, and ensuring timely and high-quality execution of all regulatory deliverables. Serve as RA Repre...
Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle to interdisciplinary project teams and to appropriate management level in Regulatory Affairs, R&D, TechOps and Supply Chain as appropriate in a timely manner. Coordinate with Regul...
Asensus Surgical is currently seeking a Regulatory Affairs Specialist to join our European Quality & Regulatory team, which is part of the Global QA/RA organization. The Regulatory Affairs Specialist will help in the development and maintenance of Technical Documentation for MDR CE Certification and...
Assists with other regulatory documentation as required by FDA and individual countries. Prepare global regulatory files/submissions for product registration as assigned. Assist in the review of proposed design changes and ECOs to assess regulatory impact. Assist the Specialists in assembly and upda...
Support cross-functional projects through the provision of regulatory submission/compliance strategy document, regulatory inputs, and documentation reviews (CER, IOVV, Risk Management Documentation, etc. Bachelor’s degree required in Life Sciences, Business Administration, Nursing or Medical Technol...
Regulatory Strategy (Intermediate): Demonstrates ability to successfully prepare long-range plans for a major regulatory requirement. Initiates requests for data analytics to identify potential regulatory risks. Regulatory Documentation (Intermediate): Writes clear, concise and comprehensive documen...
MUST HAVE + years of Regulatory experience in the IVD space. ...
The Director of Regulatory Affairs & Quality will lead the Philips RespirTech InCourage Vest Therapy Regulatory Affairs and Quality teams in the development and execution of compliant regulatory strategies and quality team/QMS responsibilities. Leading Regulatory Affairs strategy end-to-end executio...
The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for Philips' Disease Management Solution products, ensuring and maintaining global accurate regulatory strategy and market access, directly impacting the l...
Although building relationships requires business development skillsets; this position is largely focused on rolling up its sleeves and immersing itself into significant project opportunities often characterized as A pursuits. Provide clients with conceptual budgets in accelerated timeframes with mi...
Coordinate the day-to-day administrative activities of the clinical research trials program, including mentoring Research Regulatory Specialists with a focus on study activation. Lead a team of Research Regulatory Specialists and/pr Coordinators. Prepare and/or provide guidance to Regulatory Special...
Structural Engineer / Project Manager. As a Structural Engineer/Project Manager for Civil & Environmental Consultants, Inc. CEC), you'll manage project teams to develop design calculations, drawings, and specifications for various structures for our commercial, institutional, industrial, utility, an...
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As a Technical Project Manager, you'll be the key technical resource responsible for creating and deploying technology solutions. Act as the primary lead for projects, ensuring successful delivery of business solutions. Finalize and document project business requirements and use cases. Develop accur...
The Project Manager will sit within Project Management Office (PMO) where they will engage, collaborate and align on overall EPT initiatives. We are looking for a Project Manager to lead and advise a team crossing multiple functions responsible for Global Design and Implementation of the Enterprise ...
ELCD Program Manager, Nurse Navigator. The Early Lung Cancer Screening Program Manager/Nurse Navigator utilizes a defined and proven set of steps to ensure the proper follow up of CT screening examinations and diagnostic testing is completed on time. Assists the Medical Program Manager with manageme...
As an Entry-Level Environmental/Stormwater Compliance Specialist, you will play a key role in supporting our commitment to environmental stewardship and regulatory compliance. Entry-Level Environmental Compliance Specialist (Stormwater). Monitor and report on compliance with permit requirements, and...
Job Title: Salesforce Project Manager. We are seeking a motivated and experienced Salesforce Project Manager to join our team. You will work closely with our clients to understand their business needs, develop solutions that meet their goals, manage communications and project expectations, and keep ...
We are seeking a dynamic, passionate self-starter to join the Global Road Safety team as Senior Program Manager, Safety. This role also requires developing a culture of safety and implementing training programs for 3rd party carriers, as well as scoping large projects, managing project timelines, id...
At least 10 - 15+ years' experience in pharmaceutical regulatory affairs with significant experience in global regulatory affairs activities. Provide regulatory affairs project management including timelines and tracking of ongoing regulatory activities and supporting departmental budgeting activiti...
As a lead in the building, the **Program Manager** will treat patients while getting leadership experience with administrative tasks, such as scheduling and serving as a liaison for Area Manager. Program Manager - Outpatient Therapy in an Assisted Living community**. With a **Program Manager Outp...
The HR Compliance Analyst will also be tasked with conducting audits and analysis to ensure the compliance of our third-party vendors, payroll tax activities, and HR functions. We are in the process of searching for a HR Compliance Analyst who will be based in Collierville, Tennessee. Minimum of 5 y...
Corporate Scientific & Regulatory Affairs Director, Additives & Ingredients. Corporate Scientific & Regulatory Affairs Director, Additives & Ingredients leads cross-segment SRA initiatives related to additives, ingredients, and regulated undesirable substances. Demonstrated understanding of human an...
We are seeking a detail-oriented and experienced Compliance Specialist to join our compliance team. The Compliance Specialist will play a critical role in ensuring that VRC Companies, LLC (VRC) adheres to all regulatory requirements, industry standards, and internal policies related to the privacy, ...
One the top Commercial Painting companies in the area is looking to add a successful Paint Project Manager to their team! With a focus on Commercial Building projects in diverse markets, this company provides premier services that continue to attract new and repeat clients!. Paint Project Manager Re...