Collecting information
Organizing data
The Nursing Supervisor RN oversees hospital nursing staff to ensure quality patient care and regulatory compliance. Responsibilities include managing personnel, staffing, budgeting, program development, and staff training. The Nursing Supervisor will also participate in program development and training for nurse-recruitment activities and assist with continuing education programs. ScionHealth has a comprehensive benefits package for benefit-eligible employees that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. nursing supervisor, registered nurse, patient care, staff management, healthcare compliance, nursing education, hospital administration, clinical supervision, nursing protocols, healthcare records
TrueCare - Full Time - Friday 8 AM - 5 PM | Potential Saturdays Employed Loan Repayment Sign-On Bonus Compensation: The pay range for this role is $98,000 - $140,000 annually. This role supervises designated Behavioral Health Clinicians (BHCs), provides consultation on complex cases, participates in chart reviews and case conferences, and collaborates with interdisciplinary teams to improve patient care and clinic operations. The clinician delivers routine, acute, and preventive behavioral healthcare, assesses and treats a range of conditions, and ensures accurate, timely documentation in the EHR. The position supports quality improvement initiatives and fosters a patient-centered environment. Requires a Ph. D./Psy. D., MSW, or MFT degree; CA licensure as a Psychologist, LCSW, or LMFT; 3 years of clinical experience; and strong knowledge of trauma-informed care, crisis intervention, and EHR systems.
My client is seeking a driven Senior Regulatory Affairs Associate to support U.S. and global submissions for innovative devices developed in Carlsbad, CA. Your work will directly impact patient access to groundbreaking neuromodulation therapies.. Help bring cutting-edge neuromodulation devices to market. Serving as a subject matter expert on regulatory guidelines and inspections. 8+ years of experience in medical device regulatory affairs. Knowledge of neuromodulation products or similarly complex devices is a plus
Director of Patient Care Services (DPCS)- Home Health - Registered Nurse (RN). We are seeking an experienced Director of Patient Care Services or RN Clinical Supervisor for San Diego, CA. RN License Required.. This is a full-time, permanent, salaried position with a trusted Home Health and Hospice operator.. Experience working in long-term care, hospice, home health, palliative care, or hospital environment — preferably as a Nursing Director or DON. Has been featured in The Wall Street Journal, Fortune, Business Week, CNN
We are one of the largest private duty nursing companies in the nation and growing!. Pediatric Patient -G,T,V both AM shift and NOC Available!. Weekly and/or Daily Pay. Our homecare is always delivered from a place of heartfelt compassion and empathy, and every one of our Registered Nurses (RN)s works together to make sure we achieve outstanding clinical outcomes. As an employer accepting Medicare and Medicaid funds, employees must comply with all health-related requirements in all relevant jurisdictions, including required vaccinations and testing, subject to exemptions for medical or religious reasons as appropriate.
Sr. Regulatory Affairs Specialist. A leading designer, developer, manufacturer, and marketer of innovative medical devices used in spinal surgical procedures, Spinal Elements combines leading medical device technologies, biologics, and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations.. The Senior Regulatory Affairs Specialist is a key member of the Regulatory Affairs team and reports to the Associate Director, Regulatory Affairs.. Additionally, the team works closely with cross-functional departments to support product development, submissions, and post-market surveillance activities.. The Senior Regulatory Specialist is responsible for the coordination and preparation of document packages for regulatory submissions for new and mature products, ensuring alignment and compliance with local, regional, and global registration requirements, as well as company policies.
Perform selected nursing and administrative/clerical duties that assist in the delivery of primary health care and patient care management under the direction of a physician.. · Under proper supervision by a physician and/or laboratory director, perform specimen collection and simple laboratory testing common to a private medical practice, such as: urine drug tests, breath alcohol tests, urinalysis, blood glucose by finger sticks, etc.. · Prepare and maintain supplies and equipment for treatments, including sterilization.. · Adjust to quality assurance policies and procedures concerning all physical therapy issues.. · Obtains revenue by recording and updating financial information; recording and collecting patient charges; controlling credit extended to patients; filing, collecting, and expediting third-party claims.
The Associate Director of Regulatory Affairs is responsible for managing day-to-day Global Regulatory Affairs activities related to Sentynl’s development and commercial pharmaceutical programs.. The Associate Director, Regulatory Affairs will be responsible for supporting regulatory strategy implementation for U.S. and global programs and will work closely with the VP of Regulatory Affairs and Quality to prepare regulatory submissions (authoring, reviewing, timeline planning, etc.. Knowledge Experience and in the preparation of regulatory submissions, i.e. US IND, NDA, and EU Marketing Authorization Application (MAA), and other potential global territories preferred.. The pay range for the Associate Director Regulatory Affairs will be a base salary of $130k to $200k.. Unlimited PTO – based upon our trust of employees to manage their work schedule and mutual agreement between the employee and their manager.
Join to apply for the Associate Director - Hematology, Oncology Data Sciences & Digital Health role at Johnson & Johnson Innovative Medicine. You will report to the Head of Hematology & Oncology Data Science.. Serve as primary business leader for Data Science & Digital Health programs for robust Hematology Oncology portfolio.. Work closely with individual clinical teams as well as functional area partners (e.g., Translational research, Precision Medicine and diagnostics, Regulatory Affairs, Market Access, Clinical Development) to identify and implement end-to-end Data Science solutions aimed at facilitating decision making.. Advance degree in Health Science (Ph. D or MD) or Masters Degree, Pharm D with equivalent work experience in pharmaco-epidemiology, statistics, computational science, outcomes research or related field in health care area.
The purpose of the role is to provide nonclinical regulatory toxicology expertise on R&D project teams supporting the successful initiation of clinical trials and achievement of registration for drug candidates of various modalities.. The Director level PTM leads cross functional associates (i.e. Preclinical Safety (PCS) target team) to develop integrated nonclinical toxicology study plans, drafts regulatory responses and all required submission documentation and manages the respective project communication strategy within PCS.. Leads PCS Target Teams to integrate and interpret results of nonclinical safety assessment program including impact to drug development and/or project timeline. Negotiates with Global Health Authorities (HA) worldwide regarding safety issues, scientific interpretation and acceptability nonclinical safety package to support clinical trials and market approval.. PhD in Pharmacology, Toxicology or a related biological science or an MD/DVM/ PharmD or equivalent with a strong background or equivalent work experience
Our Company Gentiva Hospice is a member of the Gentiva family – an industry leader in hospice, palliative, home health, and personal home care.. Overview We are looking for an Executive Director Specialist RN to serve in any one of our California offices to cover for leadership PTOs, LOAs, and vacancies.. This role will manage budgets and ensure that organizational goals are in keeping with conscientious, humane care of patients while complying with all federal and state guidelines.. Strong regulatory affairs and governance requirements for healthcare. Gentiva provides associates with a comprehensive benefits and total rewards package, of which base pay is just one piece.
Specific tasks may include design of clinical development program plans, as well as clinical protocol development, medical monitoring of clinical trials, and analysis of study data and preparation of trial reports and related regulatory documents.. This individual will have a solid understanding of all phases of clinical drug development with particular expertise in first in human/early phase clinical trials, translational science, and operational excellence.. Assist in the preparation and review of documents for regulatory reports including drafting of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports (DSUR), and other FDA/HA submissions. MD, DO, PharmD or equivalent degree with 5+ years of clinical/clinical research experience in academia, industry or similar setting with a minimum of 3 years of Biopharmaceutical Industry experience; 5+ years Biopharmaceutical Industry experience will be a plus. It is the policy of Qpex Biopharma to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.
You shouldn’t have to be a tech expert or a math genius to take charge of your health.. Must have working knowledge of FDA, ISO, EU, and other applicable regional regulations for handling complaints, reporting incidents, and implementing corrective and preventative actions (CAPA). Knowledge of medical device processes in the following areas : reliability, sterilization, usability, software, cybersecurity, biocompatibility, performance testing, etc.. Please refrain from forwarding resumes to the Talent Acquisition team or employees.. Create a job alert for this search Regulatory Specialist
A global leader in medical technology is seeking an experienced and driven Regulatory Affairs Specialist / Manager to join their team in California.. Proven track record with successful 510(k), EU MDR, and PMA submissions. Ensure compliance with evolving regulations, including FDA Medical Device Regulations and EU-MDR, by supporting regulatory initiatives. Support business export control (BEC) listings, facilitating global product releases while maintaining compliance. Create a job alert for this search Regulatory Specialist
Conducts surveillance of workforce activities and uses statistical sampling, audit, and observation techniques to evaluate compliance with policies and procedures and adherence to contract requirements.. Provides monitoring reports to QA Manager.. Computer literate, able to use various software programs for correspondence, reports, statistical compilation and analysis, and database access. With a dedicated and passionate team, Equus puts the industry’s best practices to work by focusing on the development, design, and delivery of demand-driven workforce solutions. Equus Workforce Solutions is proud to be an Equal Opportunity Employer.
Specialized experience must demonstrate the following: monitoring and evaluating contract quality assurance programs to ensure compliance with contract specifications for ship repair and overhaul.. Specialized experience must demonstrate the following: providing assistance in monitoring contract quality assurance programs to ensure compliance with contract specifications for ship repair or overhaul.. Successful completion of a master's degree or equivalent graduate degree with major study in quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, textiles, or another field related to the position.. A bachelor's degree with superior academic achievement with major study in quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, textiles, or another field related to the position.. Industries Government Administration and Strategic Management Services
The individual will be responsible for providing education and support to trial team staff in the implementation of, and adherence to processes and workflows, controlled documents, tools, and templates to enhance the quality of study documents and the TMF. Incumbent will identify process improvement opportunities and will support process re-engineering.. Incumbent will contribute to the development of training materials while serving as a subject matter expert in both QA, QC and TMF. Incumbent will participate in the creation of a quality and education program through which staff involved in the conduct of clinical research, therapeutic and non-therapeutic protocols, will be educated and trained on current industry standards.. Act as subject matter expert and TMF point of contact for study teams and partners. Performs key TMF duties in accordance with established guidelines and work instructions (e.g., TMF set-up, management, completeness and timeliness monitoring, reports and metrics, closeout, and TMF quality control (QC) / quality assurance (QA) activities, etc.). Collaborate with study teams to ensure all appropriate documents have been filed prior to specific study milestones (e.g., site activation, amendments, close-out and TMF delivery) or according to contract requirements
It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. Knowledge of cGMP, GLP, Eudralex Volume 4, and ISO regulations are a plus. Bachelor’s or Master’s degree in Chemistry or closely related science field from a four year college/university or equivalent education and job experience; at least one year of previous employment history in a regulatory environment such as GMP/GLP, ISO or equivalent. Familiarity with at least one scientific technique (HPLC, GC, etc.)
The individual will be responsible for providing education and support to trial team staff in the implementation of, and adherence to processes and workflows, controlled documents, tools, and templates to enhance the quality of study documents and the TMF. Incumbent will identify process improvement opportunities and will support process re-engineering.. Incumbent will contribute to the development of training materials while serving as a subject matter expert in both QA, QC and TMF. Incumbent will participate in the creation of a quality and education program through which staff involved in the conduct of clinical research, therapeutic and non-therapeutic protocols, will be educated and trained on current industry standards.. Act as subject matter expert and TMF point of contact for study teams and partners. Performs key TMF duties in accordance with established guidelines and work instructions (e.g., TMF set-up, management, completeness and timeliness monitoring, reports and metrics, closeout, and TMF quality control (QC)/ quality assurance (QA) activities, etc.. Collaborate with study teams to ensure all appropriate documents have been filed prior to specific study milestones (e.g., site activation, amendments, close-out and TMF delivery) or according to contract requirements
It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations.. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.. Knowledge of cGMP, GLP, Eudralex Volume 4, and ISO regulations are a plus.. Bachelor’s or Master’s degree in Chemistry or closely related science field from a four year college / university or equivalent education and job experience; at least one year of previous employment history in a regulatory environment such as GMP / GLP, ISO or equivalent.. Familiarity with at least one scientific technique (HPLC, GC, etc.)