Collecting information
Organizing data
Conduct in-service education programs on OSHA, CDC, and JC requirements to enhance staff knowledge of regulatory standards.. Lead the JC Task Force to ensure ongoing compliance and accreditation readiness.. Education: Bachelor's degree in Nursing, Healthcare Administration, or a related field (required).. Working knowledge of hospital operations, JC standards, CMS requirements, and DOH regulations (required).. In-depth understanding of healthcare regulations with a focus on patient safety and performance improvement.
MCRA, an IQVIA business, is a leading medical device advisory firm and clinical research organization (CRO). Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices. MCRA, an IQVIA Business is seeking a Director, Cybersecurity Regulatory Affairs with working knowledge and experience with FDA requirements for cybersecurity to provide consulting advisory services to MCRA clientele. As a critical piece of MCRA’s Digital Health programs, this position will support medical device regulatory and FDA cybersecurity knowledge for the client product lifecycle – from device development, through and beyond device deployment. MCRA, an IQVIA business, is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices.
Xenon Pharmaceuticals ( NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. Build effective partnerships with cross-functional teams (e.g., regulatory affairs, clinical development, biometrics). Extensive experience writing regulatory submission documents across all phases of drug development (e.g., clinical protocols, Investigator’s Brochures, clinical study reports, briefing books, INDs/CTAs, NDAs/MAAs). Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
We’re the largest consumer-directed home care agency in NY State, and are continually expanding our areas of focus including operations in other states and tech-based innovations.. This role will have a deep understanding of healthcare regulatory frameworks and risk management, the Director of Regulatory Affairs & Compliance will ensure FreedomCare’s policies, procedures, and operations comply with laws and regulations.. Regulatory Compliance Management: Manage operational plans to ensure compliance with CMS, OMIG, state DOH departments, HIPPA, TCPA, anti-kickback statues, False Claims Act, Stark Law and other relevant regulations. Cross-functional collaboration: Collaborate with internal teams such as Legal, Operations, Marketing, National Expansion, Technology, Clinical, Physician Practice, People & Culture, and others to ensure cohesive compliance efforts. Industry Expertise: Maintain up-to-date knowledge of laws and regulations impacting Medicaid and home care Ideal Candidate Will Possess: Bachelor’s degree in healthcare administration, business or a related field.
The University of California, Los Angeles (UCLA) invites applications for the position of Associate Director of Clinical Theranostics Research at the Assistant or Associate Professor level within the Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology.. Assume clinical responsibilities, including conventional nuclear medicine, PET/CT and therapeutic and theranostic nuclear medicine services.. Play an integral role in the dosimetry program, integrating personalized radiation dose estimation into clinical research protocols and patient care pathways,. Significant experience in clinical trials, preferably in the theranostic or molecular imaging space.. ACRP certification, expertise in regulatory affairs and regulatory submissions, IND filings, engagement with the FDA, IRB submissions, GCP, and CITI
Arcellx is a public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases.. Maintain detailed knowledge of global regulatory environment relevant for cell therapies and regenerative medicine.. Join us in our quest to reimagine cell therapy and destroy cancer.. Director, CMC Regulatory Affairs Biologics. Clinical Research Regulatory Affairs Manager
At GSK, we’re uniting science, technology, and talent to get ahead of disease together.. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive.. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).. GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
Develop and implement regulatory strategies for medical devices, ensuring compliance with global regulations (FDA, EU MDR, Health Canada, TGA, etc. Advise on the appropriate regulatory pathways (e.g., 510(k), PMA, CE marking) based on device classification and target markets.. Support post-market surveillance activities, including adverse event reporting, vigilance reporting (e.g., MDR in Europe), and periodic reviews of product performance in the market.. Experience with international regulations (e.g., EU MDR, TGA, Health Canada) and global market access strategies.. Familiarity with emerging regulations such as the EU IVDR or FDA’s Digital Health initiatives.
Risant Health is seeking a dynamic and experienced Healthcare Informatics Lead. The person in this role will be at the forefront of engagement with Risant Health Organizations (RHOs), serving as a trusted advisor throughout the electronic health records (EHR) implementation and optimization journey.. Work can be done either in person in Washington D.C., Greensboro, NC or Danville, PA, fully remote, or hybrid.. Define the vision and strategy for EHR implementation services with a focus on Epic within the Informatics team.. Create thought leadership content, marketing materials, and attend industry conferences.. Proven leadership and experience with more than three (3) ambulatory or population health Epic implementations.
REGULATORY AFFAIRS MANAGER The Opportunity The function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation.. Experience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions.. Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
At GSK, we’re uniting science, technology, and talent to get ahead of disease together.. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive.. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).. GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
Medical Laboratory Scientist, Full Time Evenings, Core Lab, CMC Atlantic Health System Pompton Plains, New Jersey. Medical Laboratory Scientist II Baylor Scott & White Health Fort Worth, Texas. Health Technician - Pedorthist Amended Veterans Affairs, Veterans Health Administration Vero Beach, Florida. Medical Laboratory Scientist II Baylor Scott & White Health Irving, Texas. Medical Supply Technician - Sterile Processing Services Veterans Affairs, Veterans Health Administration Eugene, Oregon
Join to apply for the Regulatory Affairs Manager role at Capstan Medical. This is a unique opportunity for an experienced Regulatory Affairs professional to join a well-funded, early-stage start-up positioned to revolutionize structural heart care.. The Manager of Regulatory Affairs will help build and execute the regulatory strategy for our novel implant, catheter, and robotic platform products.. We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off.. Sign in to set job alerts for “Regulatory Affairs Manager” roles.
The Associate / Senior Regulatory Affairs Associate will play a key role in Regulatory Operations, focusing on the collection, preparation, and management of regulatory documents and submissions activities.. Additionally, the Associate / Senior Regulatory Affairs Associate will ensure all regulatory requirements and compliance standards are met throughout the document development and submission process.. Collaborate with external CROs / vendors to faciliate the efficient transfer of clinical trial regulatory submission documents and completed FDA Agency electronic submission documents to electronic document system (i.e., Veeva Vault).. Develop and manage electronic document system tools, including dashboard and reports, in Veeva Vault to enhance submission transparency and streamline efficiency.. Monitor and track regulatory activities, update metadata and attributes in Veeva Vault regularly, and ensure all submission records are accurate, complete, and up to date.
Guided by a population health model of care, Essen has five integrated clinical divisions offering services in primary & specialty offices, urgent care centers, and nursing homes, as well as house calls for home-bound patients; all clinical services are also offered via telehealth.. Our Care Management division supports patient-centered care through care coordination, complex care management, and helping address health-related social needs.. Job Summary The Quality Assurance Specialist will be responsible for ensuring that our services meet the highest quality standards and compliance requirements.. Other Duties: Projects or tasks assigned by House Calls Management.. College degree or equivalent; additional education or certification in healthcare administration or a related field is preferred.
This position sits within the Office of Research and Development and plays a significant role in structuring and negotiating basic-, service- and clinical-research agreements with corporate sponsors, and other collaborating organizations. Juris Doctor is strongly preferred and may substitute for required experience. Familiarity with intellectual property, technology transfer, conflict of interest and conflict of commitment concepts. Familiarity with development of corporate-sponsored research budgets for both basic and clinical research projects, including a basic understanding of Medicare coverage analysis and billing concepts associated with clinical trials. Individuals may report concerns or questions to the Title IX Coordinator.
Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapies to patients. This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office. Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology.. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. On-Site: work five days per week on-site with ad hoc flexibility.
Provide expertise on translational patient safety based on biomarkers, precision medicine, and real-world data and contribute to the advancing of pipeline programs. Provide mentorship and expertise to educate and develop scientific capabilities of Global Safety Officers and contribute to Benefit-Risk assessment.. A proven and successful track record with at least 5-10+ years of experience in biopharmaceutical clinical development in at least one of the following areas: early development, safety, risk management, pharmacoepidemiology or pharmacovigilance. Experience working in basic science or clinical development, in one or more of the following domains: gene therapy, cell therapy, biologics, small molecules and medical devices. Knowledgeable of relevant concepts in healthcare, human biology, data management and systems, epidemiology, pharmacology, pharmacovigilance, drug development and statistics
The Director (Principal Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and.. Minimum 1 year of drug-development / pharmaceutical industry experience or biomedical research experience in academia / fellowship.. Academic Presentations, Biomedical Research, Clinical Development, Clinical Investigations, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Sciences, Clinical Testing, Clinical Trial Planning, Clinical Trial Support, Cross-Functional Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, Regulatory Reporting, Regulatory Requirements, Scientific Consulting.. Create a job alert for this search Clinical Research Scientist
We take pride in our creative and collaborative work environment and in delivering clinically excellent, trauma-informed, recovery-oriented services. Bridges the gap between clinical staff and IT professionals, ensuring the seamless integration of electronic health records (EHR), clinical decision support systems (CDSS) and other healthcare technologies into daily practice. Evaluates new technologies and determines when a new EHR is needed to support our strategy of scalability, sustainability, and community impact. Qualifications Bachelor’s degree in health informatics, nursing, healthcare administration, information technology, or related field and six years of relevant experience or an equivalent combination of education and experience. Previous experience with healthcare informatics or related roles and a strong knowledge of clinical workflows, EHR systems and healthcare information technology.