Collecting information
Organizing data
The Clinical Research Coordinator I will work independently providing study coordination including screening of research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.. Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research.. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service.. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals.. Working Title : Clinical Research Coordinator I - Department of Neurology (Hybrid)
Participate in proceedings before federal agencies such as FERC, CFTC, and DOE. Coordinate comments and advocacy with regional Regulatory Affairs Staff on issues affecting gas, power marketing, carbon, and trading activities; report developments to relevant groups.. Monitor legislative activity at federal and state levels; coordinate with Corporate Relations for messaging and information sharing.. Minimum of 5 years industry experience in energy regulation, mainly in the U.S. with agencies like FERC, CFTC, DOE. With over 100 years in the US, Shell is a leader in energy, petrochemicals, and refined products, operating across all 50 states with extensive infrastructure and a commitment to reducing carbon emissions while supporting society’s energy needs.
WHOOP is seeking a Regulatory Affairs Manager (Medical Devices) to navigate and manage regulatory affairs for Medical Device Software in the US. In this role, you will work with the WHOOP Medical Device Team to act as a champion of U.S. Regulatory activities throughout the medical device lifecycle.. As a Regulatory Affairs Manager, you will be responsible for various regulatory & quality functions, such as leading regulatory submissions, implementation of quality system processes, collaborating with the WHOOP Medical Device Team throughout the product development process, and ensuring compliance with the Quality Management System (QMS).. Implement post-market surveillance, including complaint handling, adverse event reporting (MDR), and field actions. Bachelor’s Degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or related field, or equivalent practical experience. Nice to Have: Experience with Consumer Wearable Products, General Wellness Products, Digital Health or Mobile Medical Applications
We are seeking an experienced Director of Regulatory Affairs to develop and execute global regulatory strategies across clinical, non-clinical, and CMC areas.. The ideal candidate will provide strategic guidance to project teams, including international stakeholders, and translate regulatory requirements into actionable plans.. Lead the development and execution of regulatory strategies across clinical, non-clinical, and CMC areas in partnership with cross-functional teams.. Contribute to global clinical regulatory plans, identify potential risks, and recommend mitigation strategies.. Minimum 10 years of regulatory affairs experience, including management of investigational and marketed products.
Lead early interactions (Pre-IND) with global health authorities (FDA, EMA, PMDA) to secure alignment on preclinical packages, first-in-human protocols, and biomarker strategies for CNS therapies.. Design integrated early development strategic plans that bridge preclinical data (toxicology, pharmacology, CMC) with Phase I/II clinical objectives, addressing unique psychiatry/neurology challenges (e.g., blood-brain barrier delivery, placebo response mitigation).. Support Phase II PoC & Phase III Readiness; Develop Phase II protocols with Go/No-Go criteria and strategies to de-risk psychiatry/neurology programs; Prepare Phase III regulatory groundwork, including End-of-Phase II (EOP2) meeting packages, safety database planning, and alignment with ICH guidelines for multi-regional trials.. Global Submission & Portfolio Strategy; Oversee NDA/MAA submission roadmaps, ensuring late-phase clinical, nonclinical and CMC data packages meet regional requirements for CNS therapies; Advise on portfolio prioritization, balancing early-stage innovation (Pre-IND/IND) with late-phase assets to optimize resource allocation and regulatory success.. Proficiency with publishing and document management tools (e.g., Veeva, Smartsheet, office timeline pro)
Join to apply for the Regulatory Affairs Manager role at Shell Energy. Actively participate in developments and proceedings before federal agencies including FERC, CFTC and DOE.. Monitor federal and state legislative activity and coordinate with Corporate Relations teams to ensure messaging alignment and timely distribution of information about any developments that impact company positions or operations.. Minimum of 5 years industry experience in energy regulation primarily in U.S. and specifically with federal agencies, i.e. FERC, CFTC, DOE.. We are excited to play a key role in the move to net carbon emissions while providing the oil and gas needed by society for many decades to come.
The Regulatory Affairs Manager is responsible for supporting the regulatory function and its activities, the.. development of regulatory strategy focused on the use of NGS technology for companion diagnostic.. Master's Degree in science, law, health policy, regulatory affairs or engineering and 3+ years of.. Doctorate Degree in science, law, health policy, regulatory affairs or engineering.. Industry experience in oncology, NGS, IVD, CDx, CAP/CLIA, and/or regulatory
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. The Regulatory Affairs Principal is responsible for serving as RA lead on New Product Development (NPD) core teams, working on medium to complicated assay, instrument, software projects and/or system projects. Bachelor's degree in applicable fields (such as biological sciences, biomedical engineering, or chemistry) with 8+ years of related work experience OR Master's degree in applicable field with 6+ years of related work experience OR Doctoral degree in applicable field with 3+ years of related work experience.. Serves as RA lead on new product (NPD) core teams including medium to complicated assay, instrument or software projects and complies, prepares, reviews, and submits regulatory submissions (Pre-submissions, 510(k), De Novo, PMA, IVDR Class A, B, C or D or WHO PQ).
Regulatory Affairs Manager - Valencia & Burbank, CA. Eckert & Ziegler Isotope Products seeks a Regulatory Affairs Manager to join our team.. The Regulatory Affairs Manager supports the Director of Quality Operations in maintaining an effective Regulatory Affairs (RA) & Quality Assurance (QA) program, and Quality Management System which consistently delivers high quality products.. Conducts customer license reviews, regulatory reviews for SS&DRs, CMDR licenses, RMLs, MDD/MDR, export control, and others as applicable.. Experience with compliance to MDSAP, European Medical Device Directives (MDD), EU MDR/IVD, FDA, QSR/QMSR, ISO standards, and other applicable regulatory requirements.
Regulatory Affairs Specialist (IVDR). On behalf of our client a medical device company we are seeking for a Regulatory Affairs Specialist to support in their transition efforts for the EU’s In Vitro Diagnostic Regulation (IVDR).. Update the labeling conversion tracking log using manufacturing schedules, fill dates, lot numbers, and change request information.. Bachelor’s degree in Biochemistry, Biology, Medical Technology, or related field.. 3+years of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management within the IVD industry.
In this pivotal on-site role, you will also provide crucial administrative and operational support to our Nurse Practitioners (NPs) and Medical Doctors (MDs) to ensure seamless workflows, efficient service delivery, and a collaborative team environment.. Provide essential administrative and operational leadership and support for Nurse Practitioners (NPs) and Medical Doctors (MDs), focusing on optimizing clinical workflows, patient scheduling, resource allocation, and inter-team collaboration to ensure seamless service delivery.. Serve as the primary operational point of contact for clinical workflow issues, providing guidance and support to LPNs, Medical Assistants, NPs, and MDs to facilitate efficient problem resolution.. Bachelor’s degree in Healthcare Administration, Business Administration, Nursing, or a related field is required.. Proficiency in using electronic health records (EHR) systems and standard office software.
Assistant Director of Nursing (Home Health Care). We're looking for a dedicated and experienced RN leader to join our team as Assistant Director of Nursing in our home health agency.. This role is perfect for a compassionate, organized clinician with a strong background in home care, pediatric and intermittent cases, and a passion for clinical excellence.. Collaborate with leadership on patient safety, compliance, and emergency preparedness. Strong knowledge of Medicare CoPs, QA/QI programs, and EMR systems
Responsible for assisting with ensuring compliance with US OSHA and Canadian Workplace Hazardous Materials Information System (WHMIS).. This includes gathering, maintaining and correcting data in to the SAP EHS database for the preparation of Safety Data Sheets (SDSs), preparation of data for regulatory reports, and responding to customer requests for information regarding regulatory compliance and products.. A minimum of a Bachelor's degree in chemistry, biology or related science field. At least 1-3 Years of experience in a Product Safety and/or Regulatory Affairs role preffered.. A minimum of a Bachelor's degree in chemistry, biology or related science field.
The MD is responsible for providing strategic leadership, operational management, operational performance, and financial oversight to ensure Queen Mamohato Memorial Hospital operates efficiently, delivers high-quality healthcare services, and remains financially sustainable.. Leading hospital management and ensuring the delivery of high-quality patient care.. Master’s degree in Healthcare Administration, Hospital Management, Medicine, or related field.. Minimum 10 years of leadership experience in hospital or healthcare management.. Further details of the vacancy can be obtained from Queen Mamohato Memorial Hospital Security Main Gate or call us on +266 2222 0000.
$1,500 signing bonus available to external hires new to MHS employment, contingent upon satisfaction of employment requirements.. We are committed to increasing access to patient-centric, affordable, and high-quality healthcare; your personal contributions are integral to MemorialCare's recognition as a market leader and innovator in value-based and other care models.. It is expected that the employee demonstrate behavior consistent with our core values: Integrity, Accountability, Best Practices, Compassion and Synergy.. The employee shall support Saddleback Medical Center’s strategic plan and participate in and advocate performance improvement/patient safety activities.. The Patient Care Technician is an unlicensed caregiver working under the direction of the Registered Nurse.
We are seeking a Regulatory Affairs Specialist (Contractor) with hands-on experience in China NMPA registration for ultrasound imaging devices. Prepare and compile regulatory submission documents for ultrasound imaging devices in accordance with China NMPA requirements. Minimum 3 years of direct experience with China NMPA registration for medical devices, preferably ultrasound. Mandarin Chinese language proficiency preferred for working with Chinese documentation and stakeholders. Ability to work remotely or in a hybrid setup from Issaquah, WA, with some flexibility for time zone coordination.
We are seeking an experienced Clinical Pharmacist for a 2-month contract assignment in Montgomery, AL. This role is ideal for a retired or semi-retired pharmacist interested in a meaningful, short-term opportunity to apply their expertise in a supportive healthcare environment.. The Clinical Pharmacist will provide comprehensive medication and disease state management as part of an interdisciplinary care team.. Support additional pharmacy operations or special projects as directed by the Chief of Pharmacy Services.. Graduate of an ACPE-accredited College or School of Pharmacy with a BS in Pharmacy or Doctor of Pharmacy (PharmD).. Prior experience in clinical pharmacy practice, including medication therapy management, medication reconciliation, and patient education.
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation.. As a Pharmacovigilance (PV) Senior Specialist, you will be responsible for adverse event management including aggregate and individual case safety report (ICSR) health authority submissions and compliance monitoring.. Demonstrated solid pharmaceutical industry experience in Pharmacovigilance/Drug Safety. Work with a passionate Pharmacovigilance and Regulatory Affairs Team. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time.
Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology. You will oversee and execute post-market regulatory activities, including medical device reporting (MDR), regulatory submissions, and promotional material reviews. Experience with electronic QMS systems such as Propel, Windchill, Arena etc. Strong understanding of U.S. regulatory requirements; familiarity with EU MDR and other international regulations preferred. Bachelor’s degree in Life Sciences, Biomedical/Bioengineering, or related field required; advanced degree and/or RAC certification preferred.
Regulatory Affairs Manager. The Regulatory Affairs Manager is responsible for the oversight and preparation of Company regulatory proceedings and related analysis, as assigned.. Work with Federal Energy Regulatory Commission (FERC), state Public Service Commissions (PSC) and Public Counsel/Advocates (OPC) including auditors and staff, along with outside auditors to provide necessary assistance and information.. You have worked with and are proficient in Microsoft Office suite, Epicor suite, UI, FRx and Business Objects.. You have a high level of initiative, leadership and enjoy self-direction.