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...
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...
Submissions will be at moderate to complex level, and relate to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. The candidate is required to work effectively with cross-functional virtual groups and global regulatory affairs contacts...
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...
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...
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...
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...
Senior Regulatory Affairs Specialist. 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/ therapeutic/diagnostic context in order to assess regulatory implic...
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 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 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...
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...
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...
The Regulatory Affairs Specialist will develop strategies and submissions for projects and issues related to regulatory documents, global submissions, investigations, product development planning, and regulatory agency interaction for blood products and biologics. Review and approve all labeling (pr...
REGULATORY AFFAIRS SPECIALIST OVERVIEW:. The Regulatory Affairs Specialist will focus on assisting with maintaining product compliance with FDA/MDSAP, ISO, and MDD/MDR requirements. DUTIES AND RESPONSIBILITIES OF THE REGULATORY AFFAIRS SPECIALIST:. QUALIFICATIONS OF THE REGULATORY AFFAIRS SPECIALIST...
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...
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,...
The Specialist II is responsible for Regulatory Affairs support of global regulatory submissions for the BSC product development process, integration of acquired products, and ongoing regulatory compliance. Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs emp...
The Senior Medical Safety Specialist works with minimal supervision on a range of medical safety activities of varying complexity in collaboration with Medical Safety team members and other functions, including Regulatory, Quality/Post-Market vigilance, Risk Management, Complaint Handling, Product D...
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...
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...
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...
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...