Regulatory Affairs Manager Jobs in Boulder, CO

Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe support of international product registrations and related regulatory affairs activities including execution of procedures and s More...

Responsibilities: The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS) Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products including regulatory responsibilities in associated change control an More...

Under the general direction of the Vice President manages the day-to-day operations and staff responsible for  both external and internal engagement on all California state regulatory matters.  For external engagement manages the ISOs participation in processes at the Califo More...

The Senior Regulatory Affairs Manager - Screening will provide direct regulatory support for IVD cancer screening products (Shield CRC and future blood-based cancer screening tests) in all stages of the product lifecycle. This role will actively lead and support development and implem More...

Senior Regulatory Affairs Manager OncologyPosition SummaryThe Senior Regulatory Affairs Manager - Oncology will provide direct regulatory support for Oncology IVD/CDx products (Guardant360 CDx and future products such as Tissue IVD/CDx) in all stages of the product lifecycle. Th More...

Responsibilities: The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials regulatory agency meetings orphan designations paediatric planning and accelerated procedures ensuring timely preparation of well organized quali More...

Senior Regulatory Affairs Manager OncologyPosition SummaryThe Senior Regulatory Affairs Manager will provide direct regulatory support for Oncology IVD/CDx products (Guardant360 CDx and future products such as Tissue IVD/CDx) in all stages of the product lifecycle. This role will act More...

Eurofins Medical Device Consulting is seeking an experienced and influential Regulatory Affairs Thought Leader to serve as a strategic partner to our marketing and sales teams and a visible representative of our brand in the marketplace. This individual will elevate our presence at tr More...

Responsibilities: The Regulatory Affairs Associate with minimal guidance prepares reviews and submits high quality annual reports with FDA within Annual report timelines and in accordance with regulatory guidelines and applicable federal laws. With minimal guidance ensure to compile More...

Responsibilities: The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS) Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products including regulatory responsibilities in associated change control an More...

Responsibilities: The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS) Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products including regulatory responsibilities in associated change control an More...

Responsibilities: Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data and reports required for submission in support of companies products. This section cont More...

Responsibilities:Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions.Review and evaluate technical and scientific data and reports required for submission in support of companies products.This section contains More...

Responsibilities: Support the Senior Director in developing and executing regional regulatory strategies for QOL. initiatives within specific regions. Contribute to providing strategic oversight and leadership to the regulatory team ensuring alignment with company objectives and regi More...

Responsibilities: Preparing documentation for international regulatory registrations. Preparing technical documentation to compliant to MDD and EU MDR. Defining worldwide regulatory requirements are necessary for regulatory approval of products. Participating in cross functional team More...

The Senior Manager Regulatory Affairs US Advertising and Promotion ImmunologyDermatology combines knowledge of scientific regulatory and business issues to enable products that are developed manufactured or distributed to meet the required legislation. Additionally the individual deve More...