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Our direct client is looking for a Director of Quality Assurance (IVD & FDA) that has a background with In Vitro Diagnostics (IVD) devices.. Our client, an innovative and well-funded IVD company, is seeking a Director of Quality Assurance with expertise in In Vitro Diagnostics (IVD) devices and FDA compliance.. This leader will oversee and grow the company's QMS, ensuring alignment with global regulations (Health Canada, FDA, EU) as they prepare for clinical trials and product launch in 2025.. Oversee new product development, including R&D, prototyping, clinical trials, validation, and commercialization.. 10 + years of overall experience in Quality Assurance within Life Science Industry (pharmaceutical, biotechnology, medical devices, or In Vitro Diagnostics (IVD) Industry)
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
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.
The Executive Director, Head of Regulatory Affairs will be responsible for overseeing all regulatory affairs activities related to the development of innovative small molecules for the treatment of cancer.. Lead all aspects of regulatory affairs, including growing a high-performing regulatory team to support the development and approval of multiple pipeline assets.. Develop and implement regulatory strategies for drug development that align with business objectives and timelines.. Provide expert regulatory guidance to cross-functional teams, including clinical development, CMC, and quality assurance.. Minimum of 10 years of experience in regulatory affairs, with specific experience in oncology drug development.
As the Director, Regulatory Affairs CMC, reporting to the Senior Director, Regulatory Affairs CMC, you will be responsible for developing and executing the CMC regulatory strategies for Olema product(s) in development and post-approval. You will provide CMC regulatory strategy support and guidance to cross-functional teams within the organization. Provide CMC regulatory expertise for global development and registration programs (e.g., INDs, CTAs, BLAs and MAAs). 10+ years of experience working in clinical research, biotech, and/or pharmaceutical company, with 8+ years of Regulatory Affairs experience within clinical research or pharmaceutical. Global CMC regulatory experience for clinical trials is required.
Eagle Global Scientific is seeking a Technical/Research Regulatory Affairs Specialist/Subject Matter Expert for Food and Drug Administration (FDA) (Part-Time, Remote). Work in preparing one's own research proposals and one's own submissions to an IRB office or to the FDA and managing one's own research portfolio will not meet the qualifications required by this section.. 3 years current (within the past 5 years) personal and direct experience in FDA clinical research protocol compliance administration and shall have personally conducted FDA focused regulatory affairs quality assurance audits of customer's research projects.. Shall meet all technical and experience prerequisites to be qualified to test for Regulatory Affairs Professional certification, such as Certified Clinical Research Professional (CCRP), Research Regulatory Affairs Professional (RAP) or other like-kind industry standard certification.. Contractor shall have prior experience in the development, planning, hosting and delivering FDA research regulatory affairs training and education materials, including but not limited to web-site materials, workshops, training presentations, and quality assurance visits and discussions related to administration of clinical trial research records.
The Head of Regulatory Affairs is a leadership position responsible for the strategic oversight of all regulatory affairs activities related to the development and registration of company products.. Regulatory submissions: Organize and oversee the preparation, review, and submission of regulatory documents to regulatory authorities, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), Marketing Authorization Applications (MAAs), and other relevant submissions.. Cross-functional collaboration: Collaborate with and provide guidance to cross-functional teams including research, development, clinical operations, quality assurance, and CMC teams to ensure regulatory requirements are integrated into development plans, clinical trials, manufacturing processes, and labeling.. Extensive experience (12+ years) in the biotech or pharmaceutical industry, with a focus on non-clinical and clinical development; minimum of 10 years in oncology regulatory affairs required; additional experience in infectious diseases preferred.. Strong knowledge of preclinical research, pharmacology, toxicology, and clinical development processes.
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.
Conducting investigations, assessing and closing deviations, determining impact of the issues that could affect product quality, safety and purity.. Reviewing of PMs, Pest Control, Calibration records, etc.. Minimum Requirements: The QA Supervisor must have at least 5-7 years of experience in an FDA regulated manufacturing environment, with 5 years specifically in Quality Assurance or Quality Control.. Education and Experience : BS Degree or BA Degree with a Science major or concentration and continuing education credits in the pharmaceutical industry through a reputable professional society.. An Associate degree with 10 plus years in pharmaceutical manufacturing experience will be considered.
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.. 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
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.. 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
As the Director, Regulatory Affairs CMC, reporting to the Senior Director, Regulatory Affairs CMC, you will be responsible for developing and executing the CMC regulatory strategies for Olema product(s) in development and post-approval. You will provide CMC regulatory strategy support and guidance to cross-functional teams within the organization. Provide CMC regulatory expertise for global development and registration programs (e.g., INDs, CTAs, BLAs and MAAs). 10+ years of experience working in clinical research, biotech, and/or pharmaceutical company, with 8+ years of Regulatory Affairs experience within clinical research or pharmaceutical. Global CMC regulatory experience for clinical trials is required.
Nurse – LPN or RN – Clinical Trials and Drug Development 8938. 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.. 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.. 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