About this role:The Senior Regulatory Specialist is responsible for activities which lead to and maintain regulatory approval to market devices. A minimum of 5 years of regulatory affairs or related experience. Additionally, the Specialist is responsible for assessment of device changes for regulato...
The Senior Regulatory Specialist is responsible for activities which lead to and maintain regulatory approval to market devices. A minimum of 5 years of regulatory affairs or related experience. Additionally, the Specialist is responsible for assessment of device changes for regulatory implications....
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,...
We are actively seeking skilled and knowledgeable professionals to join our team as Regulatory Affairs Biosimilars Per Diem Consultants. Provide expert regulatory affairs guidance and support for biosimilars development projects. Provide regulatory support and expertise during regulatory agency insp...
Actively participate in various Quality System Community of Practice teams representing Regulatory Affairs interests, assessing impact, and bringing awareness to Regulatory Teams. The Regulatory Associate is responsible for activities which lead, improve and drive efficiencies across regulatory prod...
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...
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...
Medtronic Structural Heart is seeking an experienced and highly motivated Senior Manager of Regulatory Affairs to play a crucial role in the development and execution of global regulatory strategies for innovative transcatheter valve technologies. Senior Manager, Regulatory Affairs - Structural Hear...
We are actively seeking skilled and knowledgeable professionals to join our team as Regulatory Affairs Biosimilars Per Diem Consultants. Provide expert regulatory affairs guidance and support for biosimilars development projects. Provide regulatory support and expertise during regulatory agency insp...
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...
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 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...
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. Bring Regulatory Affairs questions/...
International Regulatory Affairs 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 spec...
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...
The Business Relationship Manager (BRM) will co-create, own, and drive the global IT strategy for the assigned Quality Assurance and Regulatory Affairs (QARA) business domains in alignment with the overall strategy and under guidance of the Lead BRM. IT experience, with minimum 5 years of experience...
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...
Minimum of 7 years of regulatory affairs or related experience, or 5 years’ experience with an advanced degree (Master’s or PhD). Develops domestic and international strategies for regulatory approval of Class II and III electronic medical equipment devices. Coordinates, compiles, and submits US and...
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...
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,...
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,...
The Business Relationship Manager (BRM) will co-create, own, and drive the global IT strategy for the assigned Quality Assurance and Regulatory Affairs (QARA) business domains in alignment with the overall strategy and under guidance of the Lead BRM. IT experience, with minimum 5 years of experience...
Actively participate in various Quality System Community of Practice teams representing Regulatory Affairs interests, assessing impact, and bringing awareness to Regulatory Teams. The Regulatory Associate is responsible for activities which lead, improve and drive efficiencies across regulatory prod...
We are actively seeking skilled and knowledgeable professionals to join our team as Regulatory Affairs Biosimilars Per Diem Consultants. Provide expert regulatory affairs guidance and support for biosimilars development projects. Provide regulatory support and expertise during regulatory agency insp...