Title: Biological Regulatory Quality Assurance Specialist III. ...
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...
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...
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...
The Staff/Principal Regulatory Affairs Specialist will function as a subject matter expert and will be part of a high-performing RA team and responsible for contributing to the development of regulatory strategies, preparing U. Represent regulatory in clinical program teams and communicate regulator...
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. ...
In collaboration with the Director of Accreditation, The Accreditation and Regulatory Compliance Specialist manages all aspects of accreditation, regulatory and hospital licensure compliance across the healthcare enterprise. Identifies opportunities for improvements based on evidence based practices...
As the Regulatory Compliance Specialist, you will be responsible for planning, coordination, and execution of post market regulatory compliance activities, such as field actions assessments, commercial holds, and recalls, in addition to leading continuous improvement initiatives. We are currently se...
As an individual contributor, the function of a Regulatory Affairs Specialist II is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. Regulatory Affairs Specialist. For products division-wide: Advises and communicates to project, g...
ERM has an opportunity for an experienced biologist/regulatory specialist to join our thriving global consulting firm as a . Principal Biologist/Regulatory Specialist. Principal Biologist/Regulatory Specialist. Serve as Project Biologist/Regulatory Specialist for environmental impact assessment unde...
Kelly® Science & Clinical is currently recruiting for a Senior Regulatory Specialist for a contract opportunity with a leading molecular diagnostics company at their Sunnyvale, CA location. Senior Regulatory Affairs Associate, New Product Development. This position is a 6-month contract with th...
Regulatory Affairs Specialist will be working to build best in class products. The ideal candidate will have experience building a regulatory strategy and supporting documents from scratch, including developing, leading, and driving proactive execution of a global regulatory strategy. Acts as a regu...
Kelly® Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a 1-year contract opportunity with a leading molecular diagnostics company at their headquarters in Sunnyvale, CA. Regulatory Affairs Senior Specialist, Global Market Protection. The Regulatory Affairs Senior Special...
With 5-8 years of experience, you possess deep professional know-how and experience in regulatory affairs. Candidates have a mastery of regulatory guidance documents and requirements for FDA 510(k) submissions, Health license applications, and EU MDR technical files. Candidate expertise includes det...
Represents RA in new product development team(s) by providing regulatory guidance, such as anticipating regulatory obstacles and emerging issues, and identifying solutions, through the product development cycle and coordinating cross functional team inputs. Responsible for assessing and documenting ...
Regulatory Affairs Senior Specialist, Global Market Protection. The Regulatory Affairs Senior Specialist is responsible for serving as the RA lead on product lifecycle management project teams. This role includes completing regulatory reporting assessments for anticipated manufacturing, facility, pr...
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. ...
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...
Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. Previous medical device experience in a Regulatory Affairs capacity . ...
Our client is looking for Title: Biological Regulatory Quality Assurance Specialist III Candidates should bring- Bachelors' degree in Biological Sciences, Engineering or related field, or equivalent combination of education and work experience. Experience focused on quality systems, regulatory af...
Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products. Provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study design issues and on timing, logistics...
Title: Biological Regulatory Quality Assurance Specialist III. Experience focused on quality systems, regulatory affairs/compliance or project management. Experience focused on quality systems, regulatory affairs/compliance or project management. ...
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...
Medical manufacturer is hiring a Regulatory Affairs Labeling Specialist on a temporary basis. ...
Kelly® Science & Clinical is currently recruiting for a Senior Regulatory Specialist for a contract opportunity with a leading molecular diagnostics company at their Sunnyvale, CA location. Senior Regulatory Affairs Associate, New Product Development. This position is a 6-month contract with the...