- Exact Sciences (Boston, MA)
- …team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others. Position Overview At Exact ... in the fight against cancer. The SSS will drive product growth of Cologuard in medical practices to meet...Managers, Area Manager, Marketing, Sales Operations and Internal Sales Support . Communicates a clear and compelling description of customer… more
- Simplot (Boise, ID)
- …to promote the Regulatory Department and educate employees regarding regulatory affairs, license requirements, product registrations, and reporting. ... Director Product Regulatory and Compliance - Innvictis...into necessary process, technology, structural changes in order to support the needs of the business and regulatory… more
- Takeda Pharmaceuticals (Columbus, OH)
- …+ Significant experience in direct authoring of nonclinical summary sections to support regulatory submissions, including but not limited to IBs, briefing ... my knowledge. **Job Description** **About the role:** **Associate Director, Nonclinical Regulatory Writing and Submission Support ,** **_Oncology and Marketed… more
- Kelly Services (Redondo Beach, CA)
- …+ Lead and Support International Device Licensing and Registrations + Support Product Development Teams for New Product Submission Requirements ... Dossiers, GSPRs for CE Marking) and Post-Market Follow-Ups + Support FDA Regulatory Requirements with Creation, Reviewing,... Agencies to Expedite Submissions and Approvals + Monitor Regulatory Outcomes of Initial Product Concepts and… more
- Medtronic (Minneapolis, MN)
- …prepare submissions and reports as required by classification and geography. + Provide regulatory support to product manufacturing transfers. Provide ... regulatory support for product design, manufacturing, packaging, sterilization, and labeling changes. Provide statistical support and bridging between… more
- ThermoFisher Scientific (Madison, WI)
- …**What we do?** Develops document package necessary to support product certifications and registrations for regulatory submissions and product ... develop compliance plans for New Product Introduction. Participates on product development teams, providing regulatory strategies, timelines, and direction.… more
- Medtronic (Minneapolis, MN)
- …etc., to ensure Cardiac Ablation Solution portfolio is aligned with existing portfolio. Maintain Regulatory Affairs product files to support compliance with ... as well as communicate that information to the Project teams. + Provide regulatory support for currently marketed products as necessary.This includes reviewing… more
- Abbott (Sylmar, CA)
- …with regulatory agency specifications. Additionally, will support necessary regulatory activities required for product market entry. **What You'll Work ... full working knowledge of GTS license types, country regulatory and language requirements. + Provide support for Product and Country Experts in the… more
- Commonwealth of Pennsylvania (PA)
- Regulatory Enforcement Inspector Print (https://www.governmentjobs.com/careers/pabureau/jobs/newprint/4648634) Apply Regulatory Enforcement Inspector Salary ... dedicated person to uphold the standards of various business professions. The Regulatory Enforcement Inspector ensures a high standard of regulated business by… more
- Organon & Co. (Jersey City, NJ)
- …authoring of regulatory documentation. + Device and/or combination product regulatory experience. **Professional Skills** **Demonstrated oral and written ... include, but are not limited to: **Responsibilities** + Provide input to global product and project regulatory strategies by performing assessments of CMC… more
- Champion Pet Foods (Auburn, KY)
- …This position is required to assist with the preparation of QA and Regulatory documentation including facility audit, license renewals and maintain an accurate ... bank runs (eg, certified cheques, money orders, etc.) + Support Ingredient Management department in documenting and maintaining the... life cycle. + Update and maintain files in Regulatory SharePoint site, such as budget reports, product… more
- Globus Medical, Inc. (Audubon, PA)
- …and documents all related activates to remain in compliance + Demonstrates global regulatory expertise in product submissions and evaluates changes with local ... procedures and regulatory decisions for new or existing products + Reviews regulatory requirements from other departments for new product designs or changes… more
- Centene Corporation (Jefferson City, MO)
- …health products, procedures, and state insurance regulations. + Experience providing product regulatory proposals and recommendations. **Travel:** 20% within ... + Manage and perform quality assurance audits on department work product , including regulatory research, filings, member-facing policy documents, projects,… more
- Philips (Chicago, IL)
- …written regulatory plans that can be used to support international regulatory submissions and global product sales. + Develop and prepare product ... & Diagnostics (AM&D) business group, including providing accurate and consistent regulatory recommendations, decisions, and feedback to product development and… more
- Merck (North Wales, PA)
- …and medical teams to ensure that promotional practices are consistent with regulatory guidelines, our company's policies, and support business objectives. Serve ... and policies and business objectives. Actively participate in labeling and global regulatory team meetings to ensure support for anticipated promotional messages… more
- Merck (North Wales, PA)
- …for development for your long-term goals. **Primary** **duties/assignments** **:** + Provide Regulatory Digital Health leaders with administrative support + ... product portfolio + Build familiarity with GRACS systems enabling departmental support for initiatives, remediation efforts, and product research (ie,… more
- Microsoft Corporation (Redmond, WA)
- Are you interested in working on novel legal and regulatory issues at the forefront of cloud computing for one of the largest cloud computing companies in the world? ... in the role of Senior Corporate Counsel, Cloud + AI Enterprise Cloud Services Regulatory Compliance. The C+AI Trusted Platform Legal Team provides legal support … more
- West Pharmaceutical Services (Exton, PA)
- …The RPM will work collaboratively with cross functional teams and lead the regulatory team through all project phases to support submissions including Premarket ... project risks/technical gaps to leadership teams. + Participate in regulatory planning and support the development of...to align on deliverables for global submissions, establish key regulatory positions, and to ensure product development… more
- Cook Medical (Winston Salem, NC)
- …approvals in advance of license expirations to ensure no disruption in product availability* Collaborate with Regulatory Scientific Affairs on all high risk ... Project team leaders and assists with the regulatory strategies* Prepare regulatory submissions for new products, product changes, and re-registrations as… more
- Amazon (Arlington, VA)
- …program management status to all customers and stakeholders; . Extracts regulatory compliance requirements from license authorizations, assigns responsibilities, ... country where we will provide Kuiper services, but there is no globally unified regulatory licensing regime for a LEO system like Kuiper. The Sr. Technical Program… more
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