Regulatory Affairs Specialist III. The primary purpose of this position is to strategically plan, execute and provide oversight to regulatory activities. US, EU, ISO standards and other regulatory requirements based on geography. Responsible for planning, managing and implementing regulatory strateg...
Senior Regulatory Affairs Specialist. Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. In this role, you will lead the preparation and submission for regulatory approvals and identify and re...
The Senior Regulatory Specialist is responsible for activities which lead to and maintain regulatory approval to market devices. Additionally, the Specialist is responsible for assessment of device changes for regulatory implications. You will have the opportunity to discuss your preferred working l...
Senior Regulatory Affairs Specialist. Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. In this role, you will lead the preparation and submission for regulatory approvals and identify and re...
The Principal Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. The Principal Regulatory Affairs Specialist is an individual contributor that works closel...
The Senior Regulatory Specialist is responsible for activities which lead to and maintain regulatory approval to market devices. Additionally, the Specialist is responsible for assessment of device changes for regulatory implications. You will have the opportunity to discuss your preferred working l...
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and clarification/follow-up of submissions under review. Provide technical review of data or reports that will be incorporated into regulatory submissions. Conduct a...
We are recruiting for a **Senior Regulatory Affairs Specialist** to join our team on-site in St. Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes. Understand, investigate and evaluate regulatory history/background of class, disease/ therapeu...
Fluency in English and Spanish In this regulatory affairs specialist position, you will have the opportunity to participate in a global healthcare spin off and act as a contributing member for one of the regulatory affairs teams at the division level. The position will work with the international re...
Regulatory Affairs Specialist II. In this role, you will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Acts as a regulato...
Author and prepare regulatory submissions for new products and changes. Review significant regulatory issues with supervisors and resolve submission issues. Develop regulatory strategies and provide ongoing support to project teams. Maintain regulatory support for marketed products and prepare neces...
The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies for complex new devices and post market changes within Philips’ Ultrasound business. Develop regulatory strategies and communicate risks within regulatory strategies vs project plan...
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...
RRIC has enterprise-wide exposure to lines of business, regulatory and risk reporting stakeholders as well as the external financial reporting and regulatory reporting infrastructures and frequently coordinates with internal audit. Experience supporting Regulatory Exams (Domestic and Int'l), Audits,...
Regulatory Affairs Specialist III. The individual will apply basic regulatory understanding to support of product and teams as well as prepare US/CE regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. Additionally will handle regulator...
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...
PS&R Lead Specialist – Water. Water business’s product stewardship, and regulatory processes are performed in line with expectations established in DuPont Corporate Standards and aligned to the Product Safety Code of Responsible Care®. The Lead PS&R Specialist leads multi-functional project teams to...
The International Regulatory Affairs Specialist provides regulatory support for implantable neurostimulation therapy for the treatment of obstructive sleep apnea. Interact with international regulatory partners in local offices to support submission contents, as well as foreign regulatory agency rev...
The Advanced Regulatory Affairs Specialist provides independent support to senior regulatory staff to submit regulatory filings. This position will demonstrate advanced knowledge of regulatory changes and assist with communication to customers and regulatory authorities. Assist with regulatory respo...
The Regulatory Affairs Specialist II will support the IA business unit in meeting global registration requirements. As a regulatory process expert supporting global registrations the candidate interprets federal/state/international regulations as they apply to our products, processes, and procedures...
Remote-Spanish-Speaking-Medical Device Regulatory Affairs Specialist II. As a Regulatory Affairs Specialist II you will:. Work with the international regulatory affairs group to ensure products are registered globally based on the spinoff strategy. Field requests from global regulatory associates fo...
As a member of the Regulatory Operations team, the Regulatory Affairs Specialist II completes regulatory submissions related to market expansions as well as sustaining product line regulatory activities. Aid Regulatory Affairs team in activities such as cover letter and form preparations associated ...
Have a passion for regulatory affairs? Interested in medical software? Look no further! We are looking for a savvy and passionate Senior Regulatory Affairs Specialist to join our team here at Canon Medical! As the Senior Regulatory Affairs Strategist, you will champion U. Support legal/regulatory ac...