The Ambulatory Regulatory Compliance Specialist has a pivotal role within the organization and is responsible for ensuring adherence to regulatory standards across diverse areas. The Ambulatory Regulatory Compliance Specialist has a pivotal role within the organization and is responsible for ensurin...
A company is looking for a Regulatory & Compliance Specialist in the healthcare ecosystem. Key Responsibilities:Track state and federal legislation and regulations affecting clientsUpdate bills and rules in the online softwareMonitor Board of Pharmacy websites for relevant informationRequired Qualif...
JCW is working on an exciting search for Regulatory Affairs Specialist III for global Biotech who is expanding their growing team. In this role you will play a key role in planning, managing, and tracking of regulatory submissions and documentation for the production of biological medicines. Account...
A company is looking for a Labeling Specialist to join their team. ...
We are hiring a Senior Regulatory Affairs Specialist for our Diagnostics Regulatory Affairs team who will be responsible for new product development, on-market, and international regulatory activities associated with US FDA, EU Notified Body, and other international regulatory agencies. Autonomously...
Key Responsibilities:Develop and implement the Quality Management System (QMS) and Technical Documentation for medical devicesCommunicate, manage, and train internal teams and external partners on regulatory and quality mattersMaintain and improve the QMS, integrate regulatory processes into busines...
Job Description: Regulatory Affairs Specialist. Provide consultation and advice to regulatory specialists regarding change control and product development. Ability to interpret and apply regulatory requirements. Offer regulatory direction and interpretation on team activities. ...
Kelly® Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a 1-year contract opportunity with a leading molecular diagnostics company based in Sunnyvale, CA. Regulatory Affairs Senior Specialist, Global Market Protection. The Regulatory Affairs Senior Specialist is responsible f...
Assist in the preparation of regulatory submissions in support of IVDR implementation of Toxicology and Therapeutic Drug Monitoring Assays. Organize and assist in the review of materials for inclusion in regulatory submissions both in the EU and worldwide. Support the preparation of dossiers and sub...
Regulatory Affairs Specialist will be responsible for assisting and supporting core regulatory affairs activities for the business, in addition to supporting advertising, promotional and standards review. Provide expert regulatory advice during the product design and development phases, ensuring reg...
We are looking for a detail-oriented clinical professional to join our growing Regulatory team as a Clinical Regulatory Coordinator (CRC) or Clinical Regulatory Specialist (CRS). Clinical Regulatory Coordinator/ Specialist. Work closely with Clinical Operations and Regulatory Affairs to ensure compl...
Prefer some knowledge of Regulatory history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Submission/registration types and requirements; GxPs (GCPs, GLPs,...
Ensure all regulatory communications/updates are received, summarized, catalogued, disseminated and acted upon. Record and maintain all client communication in accordance with company policy and regulatory requirements. ...
As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment. We are seeking a Principal Regulatory Affairs Specialist to join Abbott's Heart Failure Divisi...
Regulatory Affairs Specialist will be responsible for assisting and supporting core regulatory affairs activities for the business, in addition to supporting advertising, promotional and standards review. Provide expert regulatory advice during the product design and development phases, ensuring reg...
As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Prepares robust ...
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...
Responsibilities also include keeping senior management informed of regulatory status of products and significant regulatory issues as well as maintain proficiency in global regulatory requirements. Principal Regulatory Affairs Specialist. Proven expertise in all aspects of Regulatory Affairs; Strat...
As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment. Principal Regulatory Affairs Specialist. This position performs specialized level work assignm...
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Regulatory Affairs Specialist II:. Works in close collaboration with internal customers and supports multiple projects to align on regulatory strategy to achieve business objectives. ...
Prefer some knowledge of Regulatory and/or Quality Systems history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Principles and requirements of promotion, adv...
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps...
Prefer some knowledge of Regulatory history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Submission/registration types and requirements; GxPs (GCPs, GLPs, GM...
Medical manufacturer is hiring a Regulatory Affairs Labeling Specialist on a temporary basis. ...
Assist in the preparation of regulatory submissions in support of IVDR implementation of Toxicology and Therapeutic Drug Monitoring Assays. Tasks include:o Organize and assist in the review of materials for inclusion in regulatory submissions both in the EU and worldwide. Support the preparation of ...