Collecting information
Organizing data
This is a hybrid position at Inogen facilities located in Plano, TX or Beverly, MA.. The Director of Regulatory Affairs will lead a team and activities resulting in obtaining and maintaining regulatory approval in support of Inogen business objectives and applicable global medical device regulations.. Provide regulatory support for Inogen cross-functional regulated activities such as design, manufacturing, clinical trials, audits, post-market surveillance, etc.. Minimum of 8 years of Regulatory Affairs experience focusing on submissions and global market access within the medical device industry. Experience in medical device approvals beyond in geographies such as Asia, Latin America, South America, Australia, etc.
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 MCRAs 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.
Regulatory Affairs Manager - Bilingual (Mandarin & English)Regulatory Affairs Manager - Bilingual (Mandarin & English). Get notified about new Regulatory Affairs Manager jobs in San Diego, CA. Associate Regulatory Affairs Manager (San Diego). Senior Regulatory Affairs Manager (Onsite)Regulatory Affairs Associate Director or Senior Manager. Staff Regulatory Affairs Specialist - Becton DickinsonStaff Regulatory Affairs Specialist (Hybrid) - Becton DickinsonStaff Regulatory Affairs Specialist (Hybrid)
The Executive Director, CMC Regulatory Affairs is responsible for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and marketing of drug products.. Lead teams with regulatory CMC responsibility for support of development, registration and life cycle support, and CMC regulatory strategy for United States and EU.. Creates and implements CMC regulatory strategies for CTA submissions and marketing applications.. Provides proactive guidance to internal groups (Quality, Manufacturing, etc) based on technical and CMC regulatory knowledge towards development of strategic and tactical plans.. BS, BSc, MS, MSc, PhD, PharmD, in science or healthcare preferred or equivalent relevant experience.
Piper Companies is currently seeking a Clinical Research Nurse to support a reputable and growing hospital network in Philadelphia, PA. Responsibilities of the Clinical Research Nurse. Qualifications of the Clinical Research Nurse. Compensation for the Clinical Research Nurse. Keywords: Clinical Research, RN, Nurse, CRN, Clinical Trials, Patient Safety, Patient Monitoring, IRB Submission, Sponsor Visit
Big Data Engineer - Medicare/Medicaid at Molina Healthcare in Boise, Idaho, United States Job Description Job Summary We are seeking a highly skilled and forward-thinking Big Data Engineer to join our healthcare data team.. - Build and manage batch and real-time data ingestion/extraction pipelines using tools like Kafka, Spark Streaming, and Talend.. - Enforce data quality, security, and compliance standards using tools such as Kerberos, Ranger, and Sentry.. - Contribute to data governance initiatives, including metadata management, lineage tracking, and quality assurance.. - Expertise in Big Data tools: Spark, Hive, Impala, Presto, Phoenix, Kylin, and Hadoop (HDFS, YARN).
We are seeking a Sr. Research Nurse who will provide research coordination support for complex early phase clinical trials conducted in the Drug Development Unit (DDU) in the Division of Clinical Pharmacology.. The Sr. Research Nurse will collaborate with the study's clinical team and faculty to implement multiple research protocols and will oversee study related activities.. Oversees and supports study visits for non-licensed DDU staff (e.g. study coordinator, clinical research fellow).. At the direction of the Clinical Pharmacology faculty, assists in ordering research doses of radioisotopes from a commercial radiopharmacy.. Assist in monitoring the data integrity of studies assigned to other research nurse coordinators using Quality Assurance forms maintained by the DDU.
Join to apply for the Director, Design Quality Assurance role at Calyxo, Inc.. The Director, Design Quality Assurance provides strategic representation, planning, management, direction, and guidance to meet quality engineering goals and objectives supporting new product development and sustaining commercial products.. This position directs and oversees Quality Engineering staff who contribute to and support new product development and sustaining of commercial products.. The role provides leadership in defining and implementing quality engineering policies, principles and processes that facilitate the realization of Calyxos product development objectives.. Responsibilities include leading the Design Quality Assurance team and ensuring compliance with applicable domestic and international regulatory standards (e.g., FDA, CE marking, etc.)
Regulatory Affairs Manager M/F. We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats), and wildlife.. As part of our “Diversity, Equity and Inclusion” policy, Ceva Animal Health is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants.. The RAM's primary task is to manage the Regulatory Affairs (RA) activities of Ceva’s veterinary medicinal products, maintain product and manufacturing site authorizations, ensure business continuity, and monitor RA compliance against internal and external regulations and requirements.. You have a degree in veterinary medicine or pharmacology or a master's degree in biology with additional training in regulatory affairs.
The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents.. The responsibilities also include the coordination and preparation of Meeting Content Packages and responses to regulatory authorities as well as the management and preparation of a variety of clinical documents, including clinical study reports, narratives, investigator’s brochures for Phase I to IV clinical trials, and drug safety-related documents.. Competency in the use of Documentum (or a similar document management system) is required, while some knowledge or experience with electronic publishing tools is desired.. Competency in the use of Documentum (or a similar document management system) is desired.. Teams within the Global Groups and Medical and Regulatory Affairs department: Medical Planning and Management Physicians, Clinical Research, Data Management, Biostatistics, Drug Safety and Pharmacoepidemiology, Regulatory, Preclinical Research.
Coordinates, compiles, and submits US regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports. Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as original PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, and MDR Technical Documentation. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).. Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).. Job Segment: Regulatory Affairs, Medical Device, Compliance, Clinical Research, Medical Research, Legal, Healthcare
Oversee the preparation, documentation and conduction of Quality Assurance audits of Distribution Centers, joint Ventures, X-Ray Centers, private label manufacturers, non-manufacturing suppliers of Medical Devices and Pharmaceuticals. Serve as FDA Official Correspondent for US Facilities and US Agent for foreign HS entities.. Assist with due diligence and follow-up surveillance audits as required and serve as SME for some manufacturing partners.. RAPS and ASQ or other equivalent Certifications preferred.. Participate in corporate development of methods, techniques and evaluation criteria for projects, programs, and people.
Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen.. Manages the reporting and investigation of customer/service complaints, the review of corrective actions and failure investigations, the review of Post Market Surveillance reporting and, if necessary, implements field corrective actions.. Experienced in implementing a complete QMS system to meet US FDA and ISO requirements.. Certifications is a plus: CQE, CQA(BM), CQM, 6 Sigma, ISO Auditor, etc.. Learning & Development Opportunities: On-demand online training and book reimbursement
ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection.. Oversees Regulatory Operations by developing or maintaining project timelines/milestones/submission tracking systems, and document archive systems.. Get notified about new Regulatory Affairs Manager jobs in Boca Raton, FL.. Associate Director, Regulatory Affairs - Plasma Services. Research Regulatory Affairs Specialist I
The preferred candidate will have expertise in multiple therapeutic areas, including metabolic diseases and obesity, and across drug modalities, and have led regulatory filings for IND and CTA opening studies.. Plan and execute regulatory agency engagements, such as pre-IND/CTA and scientific advice meetings, serving as the primary contact with agencies like the FDA.. Advanced degree (Ph. D., PharmD, M.D., M.S., or equivalent) in a relevant scientific discipline such as pharmaceutical sciences, regulatory science, or life sciences.. Minimum of 12 years in the pharmaceutical or biotechnology industry, with at least 10 years in regulatory affairs roles.. Prior involvement in metabolic diseases, immunology, or rare disease drug development is highly desirable.
Clinical Research Nurse to organize and coordinate care of patients on clinical research protocols in Comprehensive Cancer Center to include evaluation of patient eligibility and registration of out/in patients, monitors care and ensures proper follow up.. Manages protocols with increased clinical complexities including translational investigator-initiated research as well as multi center trials. Works with patients to ensure adherence with the protocol; serves as clinical resource for other CTO disease team members. Current State of Ohio nursing license or other relevant board or interim permit required in appropriate field; clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) preferred; considerable experience in a clinical research capacity conducting clinical research trials preferred; considerable experience in providing direct patient care; computer literacy preferred.. The OSUCCC James is the only cancer program in the United States that features a National Cancer Institute (NCI)-designated comprehensive cancer center aligned with a nationally ranked academic medical center and a freestanding cancer hospital on the campus of one of the nations largest public universities.
At Houston Methodist, the Clinical Research Nurse (CRN) position is licensed clinician who is responsible for, with minimal supervision, supporting, facilitating and coordinating the daily clinical trial activities and plays a critical role in the conduct of the study.. The CRN position works with the Performance Improvement department, sponsor, and institution to support and provide guidance on the administration of the GCP compliance, financial and other related aspects of the research study.. Performs nursing functions independently and in collaboration with Principal Investigator as approved by Hospital administration for the conduct of clinical research.. Collects, processes and ships protocol-required lab specimens; maintains supply and equipment inventory; maintains appropriate laboratory certification as well as perform study closeout procedures including post-study documentation, return of study materials to the sponsor and data archiving.. Collaborates and prepares with Principal Investigator, Institutional Review Board (IRB) and regulatory documents for submission assuring compliance with local and federal regulatory standards as appropriate and required by the research protocol.
At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed.. With a culture rooted in connection and collaboration, our employees are team members.. Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.. The Clinical Research Nurse is responsible for coordinating and overseeing clinical research operations for all assigned clinical trials and participates in assessing, planning, implementing and evaluating Compliant Patient Care in clinical research trials.. The Clinical Research Nurse carries out the research and works under the general supervision of the principal investigator responsible for the clinical trials.
Title: Quality Assurance Trainer, Pre-Authorization Verification & Eligibility (PAVE).. Formulates teaching plans for direct staff and participates in the department quality improvement plan by reviewing accounts and providing feedback to staff concerning their quality of work and productivity levels. Responsible for understanding the complexities of health insurance plans and the relationship between health plans (Medicare, Medicaid, Commercial Insurance, Blue Cross, Worker’s Compensation, MVA coverages, and self-pay. Performs quality assurance testing and work queue monitoring to assist in developing training needs as well as shadowing all PAVE positions. Knowledge of registration, verification, pre-certification, and scheduling procedures.
This is an entry-level exempt management position-Supervises the clinical research staff members in accordance with USON SOP and ICH GCP guidelines.. Ensures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations.. Supervises clinical research staff members in accordance with USOR SOP and ICH GCP guidelines.. Special knowledge of GCP and ICH guidelines preferred. Knowledge of medical terminology, nursing assessment, clinical medicine, diagnostic tests, radiology, pathology, pharmacology, hematology, oncology as it relates to clinical trials