Implements regulatory activities such as obtaining global regulatory clearances and/or approvals, preparing device listings, performing import/export requirements, fulfilling regulatory compliance obligations, and maintaining regulatory intelligence. Responsibilities: The Regulatory Affairs Speciali...
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...
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...
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 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...
Implements regulatory activities such as obtaining global regulatory clearances and/or approvals, preparing device listings, performing import/export requirements, fulfilling regulatory compliance obligations, and maintaining regulatory intelligence. The Regulatory Affairs Specialist coordinates, fa...
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...
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...
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...
Implements regulatory activities such as obtaining global regulatory clearances and/or approvals, preparing device listings, performing import/export requirements, fulfilling regulatory compliance obligations, and maintaining regulatory intelligence. The Regulatory Affairs Specialist coordinates, fa...
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...
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 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...
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 ...
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 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...
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...
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,...
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 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 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...
Implements regulatory activities such as obtaining global regulatory clearances and/or approvals, preparing device listings, performing import/export requirements, fulfilling regulatory compliance obligations, and maintaining regulatory intelligence. The Regulatory Affairs Specialist coordinates, fa...
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...