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. Senior Regulatory Affairs Specialist. Serve as RA Repre...
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...
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...
MUST HAVE + years of Regulatory experience in the IVD space. ...
Responsibility forregulatory licensing for compliance with NRC, Agreement State, DOT, EPA andsimilar regulatory agencies within the US. Radioactive Material Licensing Specialist. Radioactive Material Licensing Specialist,. Licensing to includeamendments, applications, renewals, financial assurance, ...
Responsibility forregulatory licensing for compliance with NRC, Agreement State, DOT, EPA andsimilar regulatory agencies within the US. Radioactive Material Licensing Specialist. Radioactive Material Licensing Specialist,. Licensing to includeamendments, applications, renewals, financial assurance, ...
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...
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...
Support cross-functional projects through the provision of regulatory submission/compliance strategy document, regulatory inputs, and documentation reviews (CER, IOVV, Risk Management Documentation, etc. The role will be part of a collaborative and energetic team working on regulatory submissions an...
Environmental Regulatory Specialist. For the Managing Consultant, Environmental Regulatory Specialist (Senior Level) position, we anticipate the annual base pay of $76,000 – $94,860 (USD). Federal Energy Regulatory Commission (FERC). Research, analyze and compile data for permit applications and rep...
Strategic Program Manager-Patient Monitoring. The role of the Strategi Program Manager is a highly advanced position with the primary responsibility of spearheading the creation and execution of cutting-edge business solutions within a Healthtech company. Stakeholder Management: Collaborate with key...
Program Manager - National Accounts (Nashville). Program Manager - National Accounts (Nashville, TN or Cambridge, MA). As the Program Manager for National Accounts - Hospital Patient Monitoring Standards, you will be responsible for overseeing and ensuring the adherence to patient monitoring standar...
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...
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...
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...
The Quality Assurance Specialist is guided through knowledge of the continuous quality improvement practices within the industry, current quality guidelines, client specific SOPs, and SSC procedures and policies. The Quality Assurance Specialist is responsible for supporting and implementing the qua...
As a Quality Assurance team member, the Quality Assurance Specialist coordinates and completes daily internal reviews of clinical staff documentation, focused reviews, and problem identification. Monitor, review, & analyze clinical documentation to assure the highest quality of coordinated care....
As a Quality Assurance Analyst, you will work closely with the product and development teams to develop customer-centric software products from concept to production. Bachelor’s degree or 2+ years equivalent work experience in a position with quality assurance testing is required. This is a fa...
The Associate Director of Regulatory will be responsible for the planning, management, and execution of all regulatory activities for clinical research studies conducted at AMR. The Associate Director of Regulatory reports to the Vice President of Project Delivery and Regulatory. Oversight of regula...
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...
Reporting directly to the SVP General Counsel/Chief Compliance Officer, the Associate General Counsel - Regulatory, Compliance, and IP (AGC) will establish strategy and provide legal advice and counsel relating to several subject matter areas, including FDA/TFC laws and regulations, intellectual pro...
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...
Axiom Builders is looking for a motivated Assistant Project Manager to join our team for the construction of an multi-phase mixed-use project in Nashville, Tennessee. Assist the Project Manager in developing and maintaining project plans, schedules, and. Monitor project progress and update the Proje...
Program Manager, Learning and Development. The Learning and Development Program Manager is a key individual contributor of the Human Resources team at. They will be responsible for the design, development, and implementation of high-quality, scalable onboarding and learning programs that support cli...