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. ...
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...
Title: Regulatory Affairs Specialist with a Specialty in Labeling. Partners with other functions and Subject Matter Experts (SME's) to obtain information and/or data required for regulatory submissions. Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develop...
The Entry-Level Regulatory Specialist supports the Regulatory Affairs team in ensuring compliance with applicable laws, regulations, and standards governing products or processes within the organization’s industry. Maintain regulatory databases, document control systems, and filing systems to track ...
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...
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 ...
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...
Ensure all regulatory communications/updates are received, summarized, catalogued, disseminated and acted upon. Record and maintain all client communication in accordance with company policy and regulatory requirements. ...
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 ...
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 ...
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...
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 Assistant Manager Specialist (78884-4). This position acts as a link between companies and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation. Keeps up-to-date with changes in regulatory legislation and guidelines. As...
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...
Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. Previous medical device experience in a Regulatory Affairs capacity . ...
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. ...
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...
SUMMARY: My client is seeking an experienced Regulatory Specialist that will be responsible for global regulatory compliance reporting to the Senior Regulatory Manager. WERCS), supporting new product introduction process, and ensuring compliance with country and state level regulatory requirements. ...
SUMMARY: My client is seeking an experienced Regulatory Specialist that will be responsible for global regulatory compliance reporting to the Senior Regulatory Manager. WERCS), supporting new product introduction process, and ensuring compliance with country and state level regulatory requirements. ...
Regulatory Affairs Specialist (Senior Level). We are seeking a Regulatory Affairs Specialist (Senior Level) to ensure company compliance with US FDA 510(k), Health Canada Licensing, International Device Submissions, Licensing and Registration requirements, ISO/FDA QSR, and ISO 13485. Monitor Regulat...
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 Specialist with a Specialty in Labeling. Partners with other functions and Subject Matter Experts (SME's) to obtain information and/or data required for regulatory submissions. Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solut...
Overview: The Entry-Level Regulatory Specialist supports the Regulatory Affairs team in ensuring compliance with applicable laws, regulations, and standards governing products or processes within the organization’s industry. Data Management: Maintain regulatory databases, document contro...