- Catalent Pharma Solutions (Bloomington, IN)
- **We're hiring for a Senior Regulatory Affairs Specialist to support compliance and regulatory affairs in Bloomington, Indiana!** Catalent is a ... essential to our mission: to help people live better, healthier lives. The ** Senior Regulatory Affairs Specialist** serves as the liaison to clients and… more
- Integra LifeSciences (GA)
- …and making headway to help improve outcomes. The Sr. Regulatory Affairs Specialist is a seasoned senior professional role responsible for contributing ... and upcoming regulations in the US, EU, Canada and globally. The Sr. Regulatory Affairs Specialist is responsible for providing advanced level regulatory… more
- Medtronic (Boston, MA)
- …guidance you need to own your future success. Together, we can transform healthcare. The Senior Director of Regulatory Affairs will lead the Regulatory ... be required. This role reports to the Vice President, Regulatory Affairs for the Surgical Operating Unit... staff and coach to ensure continuing development of regulatory skills + Keep Senior Management informed… more
- CSL Behring (King Of Prussia, PA)
- …biotherapies used to treat serious and often rare conditions. Could you be our next Senior Manager of Regional Regulatory Affairs ? This position is located ... a GRA NA representative for assigned projects to the Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the delivery of… more
- Bausch Health (Bothell, WA)
- …care options to consumers and physicians alike. Reporting to the Sr. Director, Global Regulatory Affairs , the Senior Manager, Regulatory Affairs ... globally distributed products. This role is not a regional regulatory but global regulatory position which under...protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and… more
- University of Washington (Seattle, WA)
- … Affairs , University of Washington, Senior Director of Business & Regulatory Affairs , UW Medicine, General Counsel for UW Medicine Nonprofit Entities (" ... Senior Director/General Counsel"). The UW Medicine Clinical Regulatory Affairs Office is part of the...representative in external conversations with prospective business partners, regulatory agencies or others on behalf of UW Medicine.… more
- Medtronic (Santa Rosa, CA)
- …Rosa, CA or Mounds View, MN. Careers that Change Lives Reporting to the Senior Manager, the Principal Regulatory Affairs Specialist will support Research ... Principal Regulatory Affairs Specialist - Structural Heart...within the Responsibilities section of this job description are representative of those that must be met by an… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …for the clinical research aspects of registration activities with a working knowledge of regulatory affairs , in the development of the project strategy and the ... Job Title Senior Director, Clinical Development & Medical Affairs...Affairs , Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance) Strategy/Portfolio Management, Global Device… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- … Affairs Senior Specialist role:** + Act as Regulatory Affairs representative for specified key projects/products/facilities/equipment. + Prepare ... Annual Reports and other duties as needed. **Primary responsibilities for the Regulatory Affairs Specialist role:** + Manages dossier compilation for product… more
- Stryker (Portage, MI)
- …onsite role based in **Portage, Michigan.** **What you will do** **The Manager, Regulatory Affairs , State Licensing, Designated Representative ** works with a ... to apply? Here are 10 reasons to join our Regulatory Affairs /Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- regulatory -… more
- Randstad US (Chicago, IL)
- …responsibilities: The Regulatory Affairs Specialist will be the regulatory representative for assigned due diligences, under the direction of the ... global regulatory affairs strategist. + chicago ,... recommendation. In addition, you may be an assigned regulatory representative for a product/s within a… more
- CSL Behring (King Of Prussia, PA)
- …and often rare conditions. Could you be our next CSL Plasma Lead for Global Regulatory Affairs , Plasma? This position is located in our King of Prussia PA, ... contribute to the vision, goals and improvement of Global Regulatory Affairs and includes collaboration with external...FDA and other health authorities. o Serve as a liaison/ representative for our submission to regulatory agencies.… more
- Philips (San Diego, CA)
- …Recommends strategies for earliest possible approvals of clinical trials applications. + Regulatory Affairs representative for the CT/AMI Systems and ... internal or external quality system audits. + Reporting to the Director of Regulatory Affairs , the Senior RA Specialist will collaborate with global team… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- …guidance changes to Corporate Quality and Regulatory Affairs . International Regulatory Affairs and Senior Leadership. **About you: To be successful ... **Job Description Summary** As Associate Director, Regulatory Affairs , you will be responsible...audits, responses, and new submissions, and RA leadership team representative . + Responsible for the global regulatory … more
- Ascendis Pharma (Palo Alto, CA)
- …activities and those of direct reports . Work is performed under direction of a Senior Regulatory Affairs professional Contribute to internal regulatory ... The Director, Regulatory Affairs will be responsible for...and potential product expansion . Acts as the company representative with regulatory authorities . Prepares and/or… more
- Amazon (Bellevue, WA)
- …Experience defining KPI's/SLA's used to drive multi-million dollar businesses and reporting to senior leadership - . Regulatory Affairs Certification (RAPS) ... the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to...medical devices. Key job responsibilities * Acts as a regulatory representative on core product development teams,… more
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare ... and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional… more
- Fresenius Medical Center (Waltham, MA)
- …of proposed product changes. + Contributes to strategic planning as regulatory representative on interdepartmental pharmaceuticals development teams. + Provides ... can be fully remote. **PURPOSE AND SCOPE:** Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product… more
- Bausch Health (Bridgewater, NJ)
- …and effective aesthetic care options to consumers and physicians alike. The Senior Manager Professional Affairs Strategy position is responsible for leading ... General Manager and will partner with our brand marketing teams, compliance, legal, medical affairs , and regulatory stakeholders to align tactics as well as the… more
- Novo Nordisk (Plainsboro, NJ)
- …directors, program and content, and field alignment directors. They will also be the senior strategic representative of medical affairs in the relevant ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...evidence team and other relevant functions + As a senior level representative of medical affairs… more