Reporting to the Director, Regulatory Affairs & Compliance, the Regulatory Affairs Specialist supports routine to complex activities in the Compliance and Regulatory Affairs Department. Submit regulatory reports such as annual Timely Access Report. Review regulatory reports for trends and refer conc...
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...
Under the direction of the Clinical Research Manager, and in compliance with University and Department policies and federal and state regulations, the Regulatory Specialist will work closely with investigators, their study teams, regulatory personnel, and sponsor partners to draft and manage study d...
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...
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. ...
SAP, RQS, Genesis) to support DMFI Regulatory activities, which includes helping develop Regulatory policies and procedures to be in compliance with evolving state and federal regulations (i. Provide regulatory guidance and approval in managing label changes relative to formula updates under trainin...
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...
We have and Urgent requirement for APAC Regulatory Affairs Specialist II, please find Below the Job description and let me know your interest. Role: APAC Regulatory Affairs Specialist II. Responsible for regulatory activities, including product registrations, regulatory impact assessment, etc. Provi...
The Opportunity This Regulatory Affairs Specialist III - APAC will work out of our Alameda, CA, location in the Diabetes Division. Advises project groups on preliminary or fully assessed regulatory strategies and Implements Division Regulatory Strategy in specific product-related activities. Provide...
Responsible for regulatory activities, including product registrations, impact assessment, etc. PAC regulatory submissions in Medical Devices or Pharmaceutical industries. ...
Regulatory Affairs Specialist III - APAC. Advises project groups on preliminary or fully assessed regulatory strategies and Implements Division Regulatory Strategy in specific product-related activities. Provides regulatory direction on team activities. Applies basic regulatory understanding to supp...
As a Senior Global Regulatory Specialist at Eko, You Will:. Assist/lead global regulatory submissions and build regulatory guidance and strategy. As a Senior Global Regulatory Specialist at Eko, You Have:. Regulatory/Global Regulatory Affairs for medical devices, and/or software as a medical device ...
Our client, the medical device manufacturing industry, is seeking a Regulatory Specialist II to join their team. Job Title:** Regulatory Specialist. Responsible for regulatory activities, including product registrations, regulatory impact assessments, etc. Experience Background (Any):** APAC regul...
Author and/or review regulatory documents fo r global market entry , Design History Files, and perform regulatory activities in support of CAPAs, recalls, and medical device reporting to achieve departmental and business objectives. This position is part of the Quality Assurance and Regulatory Affai...
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...
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. ...
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...
Leor Weinberger, director of the Gladstone-UCSF Center for Cell and Viral Circuitry, seeks a highly motivated Regulatory / Clinical Affairs Specialist to manage regulatory affairs, author and assemble IND applications, and help manage FIH studies on new antiviral gene therapeutic candidates. The pos...
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...
Senior International Regulatory Operations Specialist. As an individual contributor, the Senior Specialist will provide support for the regulatory department to ensure efficient and compliant business processes and environment. Assist in the development of regional regulatory strategy and update str...
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...
Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. Previous medical device experience in a Regulatory Affairs capacity . ...