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...
Implement regulatory activities such as obtaining global regulatory clearances/approvals, managing device listings, fulfilling import/export requirements, and maintaining regulatory intelligence. Coordinate and manage post-market regulatory reporting and compliance activities in accordance with comp...
You will lead the Regulatory Affairs department and report to the Vice President of Global Quality and Regulatory Affairs. The Director of Global Regulatory Affairs will be responsible for developing and executing regulatory strategies for drug development and commercialization ensuring compliance w...
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. Description/Comment: Responsibilities: The Regula...
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...
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...
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. Description/Comment: Responsibilities: The Regula...
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...
Senior Regulatory Affairs Specialist. Serve as RA Representative on project teams, develops regulatory submission strategies for new product launch, and provide regulatory guidance to the project teams. Maintain regulatory documentations to support compliance with regulatory requirements. Responsibl...
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 - Medical Device. Provide strategic input and technical guidance on regulatory requirements for product modifications. Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements. ...
Build and drive a Quality and Regulatory framework and strategy for the LPG businesses that supports growth and compliance readiness. Ensure compliance to quality and regulatory system requirements ( FDA CFR 820, ISO 13485/9001, IVDR) to meet requirements of regulated and non-regulated sites/product...
The Regulatory Affairs Manager is responsible for leading a team of Regulatory professionals with responsibility for developing strategies and executing on regulatory submissions to introduce new products and therapies and maintain existing products to global markets. Minimum 7 years experience in r...
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...
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...
Responsible for defining global regulatory strategies and submissions in support of new and existing marketing authorizations for products for a global business unit with focus on electromechanical devices. ...
Remote-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 for registrations,...
Maintain Regulatory Affairs product files to support compliance. 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. ...
Remote-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 for registrations,...
Remote-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 for registrations,...
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...
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...
All regulatory aspects for assigned medical devices with emphasis on global regulatory / compliance and life cycle maintenance (including labeling content ownership and change control impact assessment responsibilities) with direct responsibility for medical devices from the Acute Therapies global b...
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...