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We are hiring a Director, Regulatory Affairs to work on-site at our Medical Device client in Portland. Develop and execute regulatory strategies for new and existing medical devices to ensure compliance with global regulatory requirements (FDA, EMA, MDR, etc.. Monitor regulatory changes and update internal teams regarding potential impacts on product development and market access. Experience in manufacturing or quality assurance in an FDregulated setting, with an in-depth understanding of cGMP, QSR, MDR, and ISO13485 standards. Proven experience with 510(k) submissions and international regulatory requirements (CE marking, EU MDR, etc
The ideal candidate will have a strong background in clinical pharmacology, excellent leadership skills, and a proven track record in drug development. Develop and implement clinical pharmacology strategies to support drug development programs. Collaborate with cross-functional teams, including clinical development, regulatory affairs, and biostatistics, to ensure alignment of clinical pharmacology activities with overall project goals. Ph. D. or M.D. in Clinical Pharmacology, Pharmacokinetics, or a related field. Experience with rare diseases, oncology, or CNS would be a plus.
The Regulatory Affairs Manager C2Dx is a leadership position contributing significantly to the Quality Assurance and Regulatory team. In this role, you will be a critical team member contributing to the execution of the company strategy and Quality Management System (QMS) for an evolving medical device company. This role will provide Regulatory Affairs leadership with significant time spent managing product regulatory strategy, licensing, market authorization, and registration tasks and documents and maintaining regulatory filing documents required by various countries and jurisdictions. Continually provide and contribute towards company and process improvements to the C2Dx QMS. Prior experience within regulatory affairs in healthcare, medical device, or pharmaceutical industry is required
As an entry-level Clinical Research Assistant, you will be integral to the success of our research endeavors, providing essential support throughout all phases of clinical trials. Completion and Submission of Clinical Trials Amendments: Ensure timely completion and accurate submission of all amendments to the Institutional Review Board (IRB), adhering to regulatory guidelines and protocols. Maintenance of Regulatory Binders: Establish and maintain regulatory binders and other relevant files, organizing documentation meticulously during the review, approval, and activation process for clinical trials. Prior experience in clinical research or healthcare administration is preferred. Familiarity with regulatory requirements governing clinical research (e.g., FDA regulations, ICH-GCP guidelines) is desirable.
Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs. This position will focus on GxP compliance within Fusion Pharmaceuticals internal systems, sponsored clinical trials, manufacturing, and the R & D organization and provide quality systems oversight in preparation for commercialization. Knowledge of GxP quality systems, quality assurance, quality control, and GMP/GCP/GLP/PV audits.
We are looking for a Clinical Research Data Coordinator ready to take the next step in their career and move away from direct patient care.. Our team is expanding and we are looking for someone who is able to support data management in Oncology clinical trials.. Ensure that all regulatory paperwork (e.g., informed consent, IRB approvals) is up-to-date and available for audits.. Review data for quality assurance, ensuring adherence to study protocols and Good Clinical Practice (GCP) guidelines.. Work closely with Principal Investigators, clinical research coordinators, and other team members to support study activities.
Arthrex is a global medical device company and leader in orthopedics medical education.. Responsible for leading the Clinical Research team in the development and execution of clinical studies, ensuring compliance with regulatory requirements, and supporting new product development through clinical validation.. Maintains a leading-edge understanding of the orthopedic industry, customers, and competitors to identify new opportunities for clinical research.. Provides support to Quality Assurance, Regulatory Affairs, and Product Management departments as needed.. Microsoft Office, PCs, 3D-CAD program, and office equipment.
The Vice President of Regulatory Affairs will be responsible for developing and implementing regulatory strategies to ensure that Xenter's medical devices meet all regulatory requirements in global markets.. Lead the Regulatory Affairs team, providing direction, mentorship, and professional development opportunities.. premarket approval (PMA) applications, and international submissions.. Collaborate with R&D, Quality Assurance, Clinical Affairs, and Marketing teams to ensure regulatory requirements are integrated into product development and commercialization processes.. Minimum of 10 years of experience in regulatory affairs within the medical device industry, with at least 5 years in a senior leadership role.
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.. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.. It’s the ripple effect that changes and improves everything for your family, your community, and the world.
We have an exciting opportunity for a Principal Scientist (Director) in Translational Medicine. Development and execution of early clinical strategy for novel therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical development plans for Preclinical Candidate molecules, and clinical pharmacology studies for programs in Phases I through IV of development. Provide clinical expertise for identification and validation of novel targets, including the design of preclinical and/or clinical pharmacology experiments to validate targets and/or pathways. Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations). Interface broadly with key functions including Discovery Sciences, Preclinical Pharmacology, Pharmaceutical Sciences, Toxicology, Translational Biomarkers, Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research throughout research sites around the world.
Orbital Therapeutics is seeking a dynamic and experienced Senior Director/Vice President of Regulatory Affairs to lead the company's regulatory strategy and advise on the company's quality strategy and operations.. The ideal candidate will have deep expertise in regulatory affairs and complementary experience in quality assurance and control within the biotechnology or pharmaceutical industry.. Ensure regulatory oversight of clinical trials to guarantee compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) standards.. Experience in RNbased or gene therapy products is highly desirable.. Strong understanding of quality systems and regulatory compliance in drug development.
We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes.. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals.. The ideal candidate will work cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, and Medical Writing teams to drive the success of clinical programs.. Around 10 years of experience in clinical development, clinical research, or regulatory affairs within the pharmaceutical or biotechnology industry.. Strong understanding of GCP, ICH guidelines, and regulatory requirements for drug development.
Orbital Therapeutics is seeking a dynamic and experienced Senior Director/Vice President of Regulatory Affairs to lead the company's regulatory strategy and advise on the company's quality strategy and operations.. The ideal candidate will have deep expertise in regulatory affairs and complementary experience in quality assurance and control within the biotechnology or pharmaceutical industry.. Ensure regulatory oversight of clinical trials to guarantee compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) standards.. Experience in RNbased or gene therapy products is highly desirable.. Strong understanding of quality systems and regulatory compliance in drug development.
The role requires an individual with excellent leadership skills, a deep understanding of end-to-end oncology clinical development, and the ability to work collaboratively with cross-functional teams, including clinical, regulatory, CMD, clinical pharmacology, biomarker and translational medicine, and clinical operations.. This role will be reporting into the oncology CMO and will have direct reports.. Develop and implement writing standards, templates, and processes to ensure high-quality, compliant and consistent document delivery.. Oversee the preparation of key regulatory and clinical documents, including clinical trial protocols, investigator brochures, briefing books, clinical study reports (CSRs), clinical sections of IND/CTA/NDAs/BLAs, and regulatory submission documents.. Provide oversight and editing support for direct report responsible for authoring manuscripts, abstracts, posters, and other scientific communications.
Started by Stanford/MIT serial entrepreneurs, Ruby Robotics is maximizing patient outcomes with tissue insights at the point of care.. The VP of Clinical and Regulatory Affairs will be responsible for leading clinical strategy, regulatory submissions, compliance, and interactions with regulatory agencies (e.g., FDA, EMA).. Lead the preparation, submission, and management of regulatory filings, including 510(k), De Novo, Breakthrough, and CE Mark. Oversee quality assurance and control activities, including risk management, CAPA, non-conformance investigations, and supplier quality management.. Proven success in obtaining regulatory clearances (510(k), De Novo, CE Mark, etc.)
Whether you're a clinical research associate (CRA), clinical trial coordinator, or involved in regulatory affairs, attending these conferences can significantly enhance your knowledge and skills.. Why Attend: Gain insights into the global regulatory landscape, including updates on the European Union’s Clinical Trials Regulation (CTR).. Key Focus: The summit will focus on clinical trial innovation, precision medicine, and adaptive trial designs.. If you're looking to enhance your knowledge and prepare for the next step in your clinical research career, check out our Clinical Research Coordinator Certification course.. For those interested in a more advanced career path, the Clinical Research Associate (CRA) Certification course is an excellent resource to further your expertise in monitoring clinical trials and ensuring adherence to protocols.
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 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
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.
These scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and reimagine our disciplines.. Explores and excels in synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines.. Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data Sciences Institute (DSI) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications.. Be responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in close collaboration with key partner functions (e.g., pharmacometrics, statistics, and DMPK).. Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with key partners such as Pharmacometrics, Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs.