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...
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...
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...
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...
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 ...
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 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...
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. ...
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...
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...
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. ...
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...
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. ...
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 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...
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. ...
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...
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...
Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. Previous medical device experience in a Regulatory Affairs capacity . ...