Regulatory Affairs: salario promedio en Minnetonka, MN in 2024
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Regulatory Affairs Specialist
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 II - Electrophysiology (on-site)
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...
Regulatory Affairs Specialist II
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 - Electrophysiology (on-site)
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...
Advanced Regulatory Affairs Specialist
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...
Sr. Regulatory Affairs Specialist
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/...
Sr Regulatory Affairs Spec
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. ...
LPG Sr. Director - Quality & Regulatory Affairs
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...
Remote-Spanish speaking Regulatory Affairs Specialist (Medical)
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-Spanish speaking Regulatory Affairs Specialist (Medical)
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,...
BRM, Quality Assurance and Regulatory Affairs
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...
Regulatory Affairs Specialist
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...
Regulatory Affairs Specialist
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. ...
Senior Regulatory Affairs Specialist
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...
Prof III-Regulatory Affairs-General Regulatory Affairs
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...
International Regulatory Affairs Specialist
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
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...
Senior Regulatory Affairs Specialist
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...
Senior Manager, Regulatory Affairs - Structural Heart & Aortic (hybrid).
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...
Regulatory Affairs Biosimilars Per Diem Consultant
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...
Sr Manager, Regulatory Affairs
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-Spanish speaking Regulatory Affairs Specialist (Medical)
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
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...
Regulatory Affairs Specialist II
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 Biosimilars Per Diem Consultant
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...