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...
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...
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: 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. ...
Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. Previous medical device experience in a Regulatory Affairs capacity . ...
The Clinical Trial Regulatory Specialist I (CTRS-I) is a novice level position which, under the direction of the KPNC Clinical Trials Compliance Director or designee and Principal Investigator (PI), provides regulatory document support to the Kaiser Permanente Northern California (KPNC) PI and resea...
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...
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. ...
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...
Regulatory Affairs Manager - Permanent - San Francisco Bay Area. Proclinical is seeking a Manager, Regulatory Affairs for a global medical device company. The Manager, Regulatory Affairs will:. Leads regulatory resources to ensure timely product registrations, regulatory planning for new product int...
The Project Manager is authorized to speak for the firm when dealing with a Client or Contractor in matters concerning the interpretation of the contract documents, and is directly responsible both to the Client and the firm for the successful execution of the project. Analyze the project scope, the...
Minimum Qualifications Bachelor’s degree in food science, Animal Science, Food Engineering, International Trade, Regulatory Affairs, or other related education 5+ years of experience in regulatory compliance for international trade that includes the below experience APHIS packet creation iReg ...
We are seeking an experienced Project Manager to oversee the comprehensive execution and daily operations of project design, procurement, and construction. As the client's primary liaison, the Project Manager collaborates directly with the client, project sub-consultants, and subcontractors. Provide...
This position will be reporting into the SVP of Regulatory Affairs and will be supporting Clinical Regulatory and Regulatory CMC functions. Senior Director, Regulatory Affairs (Generalist). Meet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Affair...
Ensures that contractor is performing quality assurance (QA) of stored petroleum products, maintaining quality standards in compliance with MIL-STD 3400-C. The incumbent is the Quality Assurance Evaluator (QAE) for the alongside aircraft refueling contract. The incumbent is responsible for insuring ...
Produce regular reports necessary for Project compliance for IRA and DOL Compliance. Quickly respond to and resolve any non-conformities identified within the project site based on guidance from Compliance Specialist. Monitor apprenticeship program metrics for a project site to ensure 100% complianc...
Full Time – Grant Compliance Specialist I (GCS I). This role involves assisting in compliance monitoring and reporting, with supervision. Assist in the development of program policies, procedures, and compliance monitoring strategies, with supervision. Provide support on federal regulations, eligibi...
The Compliance Analyst complements the team with their legal, compliance, financial, and/or insurance experience. Today, we are helping companies take on some of the world’s most critical and complex issues, including retirement funding and healthcare financing, risk management and regulatory compli...
Requirements / Qualifications .Letter(s) of Recommendation (Three (3) required.Two (2) may be personal (non-relative), One (1) must be from current or past employer/supervisor....
Director, CMC Regulatory Affairs. Serve as the PDM regulatory representative on project teams, provide CMC regulatory support for the clinical development of the investigational product(s), and ensure applicable regulatory requirements are appropriately met. The position is responsible for providing...
Project Managers for large project deliveries during the following phases: planning, scope definition, design, execution, and delivery), oversight for the program during the maintenance phase and ensuring sustainment of deployed solutions, resolving technical and non-technical issues. Familiarity an...
Associate) Director, Regulatory Affairs – Permanent – San Francisco Bay Area. Proclinical is seeking an (Associate) Director, Regulatory Affairs for a clinical-stage biopharmaceutical company located in the San Francisco Bay Area. A degree in a life science, chemistry, or chemical engineering or clo...
Director of Regulatory Affairs. Represent Regulatory Affairs in cross-functional development teams and ensure alignment with regulatory requirements. As the global regulatory lead (GRL), you will work cross-functionally with teams to manage regulatory submissions and approvals, ensuring compliance w...
Authorization to work lawfully in the US without sponsorship from Simplex is required.This is an on-site, long term job.You must be in located in Southern California.NO relocation funds, and NO per diem.Required: Minimum of 3 years full time paid professional experience in the Project/Construction M...