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SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, OSHPD, CDPH Lab Field Services, CDPH Radiologic Health Branch, etc.. Actively coordinates the organization’s readiness rounds program and is primarily responsible for the development, communication, implementation and tracking of action plans necessary to close identified gaps in care or compliance with The Joint - Commission (TJC) standards and Centers for Medicare and Medicaid Services (CMS) and Title 22 regulations.. Manages onsite accreditation and regulatory surveys; supports command center activities.. Preferred Licenses/Certifications: Certified as a Professional Healthcare Quality (CPHQ) or Certified as a Joint Commission Professional (CJCP); LEAN/Six Sigma Certification.. Required Experience: Five years of hospital operations or patient care experience; two years in accreditation/licensing/regulatory compliance/ quality/performance improvement/patient safety in healthcare; experience applying quality assurance/performance improvement (QAPI) and customer service approaches; experience with Midas, Epic / Electronic Health Record (EHR), County Health Systems, OSHPD.
Kelly® Science & Clinical is seeking a Director of Regulatory Affairs for a fulltime, Direct Hire role with a pharmaceutical client based in San Fran Bay area.. Position Overview: The Global Regulatory Affairs Director will play a pivotal role in leading and managing our global regulatory strategy to ensure the successful approval and commercialization of our promising HBV small molecule drug.. Monitor changes in the regulatory landscape and assess their impact on ongoing and future drug development activities.. BS/MS/PhD in Life Sciences, Pharmacology, Pharmacy, or a related degree. In-depth knowledge infectious disease related therapeutic areas is a plus.
Coordinates global CMC regulatory activities necessary to conduct clinical trials, achieve marketing approval of drug candidates and ultimately support the life-cycle of approved products.. Supports CMC regulatory affairs activities for marketed products and compounds in development in line with US and ex-US regulatory requirements.. Supports the regulatory function on development teams providing CMC regulatory guidance and strategy including identifying and assessing/mitigating regulatory risks.. Targeting at least 8 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development.. Previous experience in the preparation and submission of the CMC components of IND/CTA and NDA and ex-US MAA submissions.
This position, Associate Director Regulatory Affairs , works out of our San Diego, CA location in the Infectious Diseases Division. This role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and U.S. Regulatory Affairs. Approve regulatory filing strategies based on proposed preclinical, clinical, and manufacturing changes. Bachelor's degree, preferably in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. 7+ years' experience in a regulated industry, +7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
This position, Associate Director Regulatory Affairs , works out of our San Diego, CA location in the Infectious Diseases Division. This role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and U.S. Regulatory Affairs. Approve regulatory filing strategies based on proposed preclinical, clinical, and manufacturing changes. Bachelor's degree, preferably in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. 7+ years' experience in a regulated industry, +7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
Quality Assurance Compliance Specialist – Medical Devices.. We are supporting a U.S.-based medical device manufacturer that designs and builds high-specification Class II medical devices within Respiratory for hospital and clinical environments. Known for engineering excellence and a strong commitment to regulatory compliance, the company has a long-standing reputation for delivering safe, effective, and durable systems that support patient care in critical settings. As part of their ongoing growth, the company is seeking a Quality Assurance Compliance Specialist to join their onsite team in Riviera Beach, Florida. In-depth knowledge of MDD/MDR, CE/CSA standards
Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific. Verathon is looking for a Director, Regulatory Affairs to become the newest member of our QA/RA Team located in Bothell, WA. This is an onsite position based in our Bothell WA Headquarters. The Director, Regulatory Affairs is responsible for managing regulatory strategies for worldwide device and registration of Verathon products, in accordance with product development and business objectives. Lead, mentor, and develop a team of Regulatory Affairs professionals and contracted clinical study, medical professionals, and other consultants.. 8+ years experience in regulatory affairs within a regulated industry (e.g., medical devices, pharmaceuticals, biotechnology, or healthcare products)
This role, reporting to the Senior Vice President of Regulatory Sciences, leads a team responsible for regulatory strategy, submissions, approvals, and compliance throughout drug development, including oversight of the Regulatory/Medical Writing Group.. The ideal candidate has experience in biologics drug development, regulatory strategy, and late-stage filings, thriving in an innovative and agile environment.. Lead global regulatory leads, regulatory operations head, tactical implementation team, and Regulatory/Medical Writing lead.. Proven track record in drug development and commercialization.. 15-20+ years in regulatory affairs within a biopharmaceutical organization.
The Vice President, Regulatory Affairs is responsible for developing and overseeing global strategies, RA operations, and global labeling to secure IND/CTA approvals for various studies as well as obtain and later maintain market approval for product(s) in oncology. Oversees Labeling Regulatory staff/contractor(s); demonstrates excellent understanding of drug development in oncology and leadership behaviors consistent with level.. Provides coaching, management, and mentoring for regulatory affairs team members.. Doctorate or Master's degree in life sciences (pharmacy, biology, chemistry, medicine pharmacology) or related field.. Minimum of 15+ years' experience in pharmaceutical regulatory activities in oncology, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU, Japan, or China
This is a contract job opportunity.. schedule Job is at a clinical research facility Preparing for upcoming studies, service healthy population of patients during clinical trial studies, dosing, watching for side effects to trials, administering trial doses, reporting and investigating side effects.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
This is a contract job opportunity.. Rotating weekends Job is at a clinical research facility Preparing for upcoming studies, service healthy population of patients during clinical trial studies, dosing, watching for side effects to trials, administering trial doses, reporting and investigating side effects.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
This is a contract job opportunity.. schedule Job is at a clinical research facility Preparing for upcoming studies, service healthy population of patients during clinical trial studies, dosing, watching for side effects to trials, administering trial doses, reporting and investigating side effects.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
The Senior Director of Global Regulatory Affairs - CMC (GRCMC) leads and manages the scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities for Lilly's synthetic molecule portfolio. Recognized as a deep scientific technical expert in CMC drug development and/or pharmaceutical manufacturing technology and processes. Ensures department has broad technical knowledge and expertise in global CMC regulatory requirements and guidelines for conducting clinical trials, obtaining global product registrations, and updating approved global product registrations for drug substances and drug products. Provides regulatory sciences leadership, decision making, guidance and coaching for CMC regulatory scientists. Ensures that global CMC regulatory commitments are defined based on approved submissions for products and communicated to Manufacturing and Quality Assurance.
Usona Institute, a non-profit medical research organization founded in 2014, conducts and supports biochemical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines. Our focus is on alleviating depression and anxiety in people for whom current medical treatments fall short in offering relief and a better quality of life. The Director, Quality Assurance provides strategic and operational regulatory leadership for Usona Institute's psychedelic drug development activities. Minimum of 10 years of progressive Regulatory Affairs experience in the pharmaceutical or biotechnology industry. Demonstrated experience with FDA regulatory submissions (e.g., IND, NDA) and successful agency interactions.
This is a contract job opportunity.. schedule Job is at a clinical research facility Preparing for upcoming studies, service healthy population of patients during clinical trial studies, dosing, watching for side effects to trials, administering trial doses, reporting and investigating side effects.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
This is a contract job opportunity.. Rotating weekends Job is at a clinical research facility Preparing for upcoming studies, service healthy population of patients during clinical trial studies, dosing, watching for side effects to trials, administering trial doses, reporting and investigating side effects.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
Nurse – LPN or RN – Clinical Trials and Drug Development 8936. Rotating weekends Job is at a clinical research facility Preparing for upcoming studies, service healthy population of patients during clinical trial studies, dosing, watching for side effects to trials, administering trial doses, reporting and investigating side effects.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
We’re seeking a Regulatory Affairs / CRA to work at a premier client in Sunrise, FL. Sound good?. Pay Rate: $ 25 - $30 /hr Why you should apply to be a Regulatory Affairs / CRA:- Join a dynamic team committed to optimizing patient enrollment in clinical trials. You’ll be:- Ensuring procedures are in place for the appropriate optimization of patients into clinical trials, while monitoring the assigned trials according to company SOPs and GCP guidelines. This job might be an outstanding fit if you:- Hold a Bachelor's degree in a relevant field and have experience in clinical research or regulatory affairs, with a strong understanding of GCP and regulatory requirements. It’s the ripple effect that changes and improves everything for your family, your community, and the world.