A company is looking for a Regulatory Specialist - Dental Operations. Key Responsibilities:Support external and internal regulatory reporting, surveys, audits and investigations impacting dental operationsMonitor incoming regulations and share regulatory guidance with dental operationsPerform monito...
As a Project Specialist supporting the Regulatory team at Virgin Galactic, you will support critical activities towards establishing and ensuring compliance with regulatory requirements related to our vehicles and mission operations. This will include establishing traceability and relationships betw...
A company is looking for a Senior Regulatory Affairs Specialist responsible for regulatory activities related to medical devices. ...
Senior Principal Regulatory Affairs Specialist - Remote. Works independently to provide strategic input and technical guidance on regulatory requirements for business-critical and new product development projects. Reviews Regulatory Strategies/Plans and Submissions and ensures consistency and alignm...
A company is looking for a Principal Regulatory Affairs Specialist for Digital Health Apps. ...
Job Description: Regulatory Affairs Specialist. Provide consultation and advice to regulatory specialists regarding change control and product development. Ability to interpret and apply regulatory requirements. Offer regulatory direction and interpretation on team activities. ...
Support the EU's In Vitro Diagnosic Regulation (IVDR) transition activities that will impact all Bio-Rad products currenlty CE Marked under the IVD Directive.Activites include preparation revision of technical files when needed, update labeling to comply with IVDR requirements, track RA Regional not...
Support QA in executing compliance activities involving NCMRs, Process Deviations, MDRs to regulatory authorities. ...
The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Provides regulatory guidance and defines regulatory strategy for digital products...
Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional Regulatory Affairs colleagues to drive timely and accura...
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...
Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Minimum five (5) years of experience in Regulatory Affairs. Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training progra...
As a Senior Specialist, International Regulatory Affairs, you complete and maintain regulatory approvals and clearances of assigned products. Representing the OUS regulatory function on manufacturing and product development teams to providing input on regulatory requirements, including presenting al...
The role of the Regulatory Affairs Specialist will be to support the global regulatory affairs of the business with a specialized focus on the United States. This position will be primarily responsible for obtaining and maintaining all necessary United States federal and state regulatory approvals f...
Real Estate/Regulatory Specialist | Irvine, CA (Hybrid) | 30 Months Project . Managing Regulatory approval requirements and ensuring compliance with all applicable regulations. ...
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps...
Provides consultation/advice to regulatory specialist for change control and product development. Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams. Handles regulatory activities involved in documentation...
He/She has responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Prin Regulatory Affairs Specialist. Sustaining regulatory responsibilities include reviewing changes to ensure that regulato...
We are seeking a Principal Regulatory Affairs Specialist to support regulatory strategies and submissions for Class III medical devices. Lead regulatory submissions for Class III devices and maintain regulatory communications. This role will involve collaborating with cross-functional teams, contrib...
In Vitro Diagnostic Regulatory Specialist (R&D/QA). Regulatory affairs, in Quality Assurance, R&D, Manufacturing or Project Management in IVDR (Vitro Diagnostic Regulation). ...
As a Specialist, Regulatory Affairs for TMTT, you will complete and maintain clinical and commercial regulatory approvals of Class III implantable products in the US and EU, focusing on the paradigm shifting transcatheter tricuspid valve replacement therapy. From design to production, our Regulatory...
Seeking a Senior Regulatory Affairs Specialist with expertise in US and EU regulatory requirements, EU MDR regulation, and medical device regulatory submissions to sustain the current product portfolio. Partner with the international regulatory affairs group to support regulatory submissions. In-dep...
Responsible for managing submission publishing, device listings, UDI data collection, and maintaining regulatory compliance for medical devices in the US and EU markets. Regulatory Operations within the medical device industry. Understanding of US and EU medical device regulations, including submiss...
As a Project Specialist supporting the Regulatory team at Virgin Galactic you will support critical activities towards establishing and ensuring compliance with regulatory requirements related to our vehicles and mission operations. This will include establishing traceability and relationships betwe...
Our client has a unique opportunity for a highly skilled Principal Regulatory Specialist to join a growing team working on novel technology in the Neurological/Spine space. Lead regulatory strategy and submissions for Class 2 & 3 products, including PMA and 510(k) applications. Develop and execute r...