- Cardinal Health (Boston, MA)
- **What Regulatory Submissions Operations contributes to Cardinal Health** Regulatory provides regulatory affairs and product development consulting ... subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting. … more
- Integra LifeSciences (Braintree, MA)
- …and making headway to help improve outcomes. The Sr. Regulatory Affairs Specialist is a seasoned senior professional role responsible for contributing to and ... in the US, EU, Canada and globally. The Sr. Regulatory Affairs Specialist is responsible for providing...strategies, and revise technical documentation for existing and new regulatory submissions . + Lead in the development… more
- Hologic (Marlborough, MA)
- …to make a global impact in the medical device industry? Hologic is seeking a ** Senior Regulatory Compliance Specialist ** to lead the charge in ensuring our ... Sr. Regulatory Compliance Specialist Marlborough, MA, United...regulations, including standards and guidance documents. + Familiarity with regulatory submissions and compliance processes. **Skills** +… more
- Bayer (Cambridge, MA)
- …facilitate improved collaboration. **Lead the preparation and/or review of IVD/CDx regulatory submissions (SRD, 510(k), IDE, PMA/CE-marking) to support clinical ... to make a real difference, there's only one choice.** ** Senior Director, Global Regulatory Leader-IVD** The ...In Vitro Diagnostics is required; + Solid experience leading regulatory submissions for IVD/CDx, including for use… more
- Edwards Lifesciences (Boston, MA)
- …representative in core team meetings in the development of reporting plans and regulatory submissions . + Lead and provide input on other complex cross-functional ... difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international… more
- Middlesex Savings (Natick, MA)
- …management reports including borrowing base reports that govern lines of credit, regulatory compliance reports, and sales and sales activity reports. Maintains and ... + Assists loan officers and the Credit Department in preparation of loan submissions including but not limited to credit analyses and loan approval requests,… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Senior Clinical Research Director **Location:** Cambridge, MA **About the Job** **About the job** Are you ready to shape the future of medicine? The ... in helping our teams accelerate progress. Join our Fitusiran Clinical Team as Senior Clinical Research Director and you will be the primary Clinical Lead for… more
- Sanofi Group (Cambridge, MA)
- …structure of the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP Supports registrations, label submissions and modifications ... you thought was possible. Ready to get started? The Senior Clinical Research Director (Sr CRD) is noted as...for research projects + Represents his/her project at key regulatory agency meetings as the medical spokesperson for the… more
- Beth Israel Lahey Health (Boston, MA)
- **Overview** **The Senior Research Administrator, Post-Award (Research Administrator II)** will, under the direction of the Director, Major Projects and Post Award ... and translate financial data so it is understandable for the non- specialist . Investigate any anomalies and provides timely resolutions. Reallocate budgets and… more