Provides consultation/advice to regulatory specialist for change control and product development. Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams. Handles regulatory activities involved in documentation...
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. ...
We are currently seeking a Senior Regulatory Affairs Specialist to drive regulatory strategies and submissions for medical devices. Senior Regulatory Affairs Specialist. Hands-on experience with major regulatory submissions and managing interactions with regulatory agencies. Develop and implement gl...
Our client has a unique opportunity for a highly skilled Principal Regulatory Specialist to join a growing team working on novel technology in the Neurological/Spine space. Lead regulatory strategy and submissions for Class 2 & 3 products, including PMA and 510(k) applications. Develop and execute r...
We are seeking a Principal Regulatory Affairs Specialist to support regulatory strategies and submissions for Class III medical devices. Lead regulatory submissions for Class III devices and maintain regulatory communications. This role will involve collaborating with cross-functional teams, contrib...
Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements. Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industr...
The Southern California Natural Resources Team is looking for a an experienced Regulatory Specialist to support permitting needs, including preparing permit applications for individual, general, and programmatic permitting efforts with the U. You will join an existing team of Natural Resources profe...
Partner with Geography RA to plan, develop and execute global regulatory activities necessary to obtain and maintain regulatory approvals in International markets (such as Canada, LATAM, EMEA). Provide support to the Geography RA who interact with re Regulatory, Specialist, International, Manufactur...
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...
Job Description:</b> As a Financial Regulatory Specialist, you will be responsible for analyzing, interpreting, and applying financial regulations to ensure the company's compliance with local, state, and federal regulations. You will work closely with various departments to provide guida...
Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. Previous medical device experience in a Regulatory Affairs capacity . ...
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...
Conducts regulatory audits and surveys by consulting on the interpretation and interaction of current regulatory policies and requirements in preparation for surveys. Identifies and recommends improvements to processes of responding to regulatory audits and survey preparedness efforts by: independen...
The Southern California Natural Resources Team is looking for a an experienced Regulatory Specialist to support permitting needs, including preparing permit applications for individual, general, and programmatic permitting efforts with the U. You will join an existing team of Natural Resources profe...
Regulatory Affairs Operations Specialist I. This new team member will perform 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 specifi...
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. ...
Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements. Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industr...
The Manager CMC Regulatory Affairs is responsible for supporting the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early and late-stage T cell therapies. Director, CMC Regulatory Affairs. Represent CMC regulatory affairs on product teams and in ...
The Program Manager, Cloverfield will be responsible for administrative oversight, and supervision of line staff for this Interim Housing Program for The People Concern. Program Manager (Wed-Sun, 4pm-12:30am). This position is responsible for maintaining the highest quality services and efficiency o...
The AD CMC Regulatory Affairs supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies. This position is hybrid, and based in Santa Monica, CA and reports to the Executive Director, CMC Regulatory Affairs. You will...
The Manager CMC Regulatory Affairs is responsible for CMC technical document review and writing, authoring and compiling the CMC sections for global regulatory filings by working closely with the cross-functional teams including CMC, Quality, Clinical and Regulatory Affairs to ensure all Regulatory ...
Lead legal team members supporting the successful development and implementation of products, programs, and projects. Project Management Institute, Inc. JobPosting","title":"Manager, Global Compliance","datePosted":"2024-08-26T00:00:00","validThrough":null,"description":"What you will be doing\nYou ...
A degree in a life science, chemistry, or chemical engineering or closely related discipline with a graduate degree preferred and at least 10 years of experience in pharmaceutical regulatory affairs, that includes, but cannot be limited to, CMC regulatory affairs. Associate) Director, Regulatory Aff...
They are looking to bring on a Senior Director, Regulatory Affairs to the team. Provide strategic and operational leadership in regulatory affairs, including regulatory strategies, clinical study requirements, and marketing approvals in various regions. Utilize deep knowledge of regulatory requireme...
Director/Senior Director, Regulatory Affairs. They are looking for a Director or Senior Director of Clinical Regulatory Affairs to join their team. Develop and execute Clinical Regulatory Affairs strategies to support clinical development objectives. Minimum 7 years specifically in clinical regulato...