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. ...
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...
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...
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 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...
To help grow and maintain the regulatory and quality standards, we are seeking a Regulatory Affairs (RA) and Quality Assurance (QA) specialist to provide RA-QA support and leadership to ensure compliance with FDA QSR, ISO 13485, and MDSAP for all SprintRay products as well as implement and maintain ...
Maintain or create technical/regulatory documentation such as IL, QIL, QF and SDS. Review artwork for fill weight claims, ingredients and regulatory issues. Assist with developing technical documents for new/existing products to meet regulatory and customer needs. High school Diploma or GED and 1-3 ...
Job Title: R&D Regulatory Specialist. Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and ta...
Seeking a Principal Regulatory Affairs Specialist to support the Kindeva business in maintaining regulatory compliance of existing manufactured products for customers on a global basis by:. Managing regulatory compliance activities for Kindeva and existing customer products and registrations as requ...
Maintain or create technical/regulatory documentation such as IL, QIL, QF and SDS. Review artwork for fill weight claims, ingredients and regulatory issues. Assist with developing technical documents for new/existing products to meet regulatory and customer needs. High school Diploma or GED and 1-3 ...
Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle to interdisciplinary project teams and to appropriate management level in Regulatory Affairs, R&D, TechOps and Supply Chain as appropriate in a timely manner. Coordinate with Regul...
Regulatory Affairs Operations Specialist I (on-site). 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 product...
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. ...
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...
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...
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...
Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. Previous medical device experience in a Regulatory Affairs capacity . ...
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...
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...
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...
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...