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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.. 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.. 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
Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services.. Client Services As the corporate subject specialist in regulatory affairs, provide regulatory, ethics and/or pharmacovigilance guidance and support to project stakeholders.. Project Support Regularly respond to registration requests and work with project teams to identify regulatory requirements.. Qualifications Applicants should have a minimum of an undergraduate degree and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs.. Working Conditions Home-based *Accommodations for job applicants with disabilities are available upon request.
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.. 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
A mid-size and growing medical device manufacturer specializing in class III vascular devices are looking for an experienced Director of Regulatory Affairs to drive regulatory excellence in this field.. Ensure compliance with FDA, EU MDR, and other international regulatory requirements for high risk medical devices.. 10+ years of regulatory affairs experience in the medical device industry, with some experience in class III devices (ideally vascular).. Strong knowledge of FDA regulations, EU MDR, and other global regulatory requirements.. Join a forward-thinking company at the forefront of vascular access.
In this role, the VP of Regulatory Affairs will draw on extensive experience and strong leadership and organizational skills to develop and implement the global regulatory strategy for all company assets.. Lead the Regulatory Team that may include external consultants or other Clinical or CMC Regulatory Affairs personnel, Regulatory Medical Writing, Quality Assurance and Pharmacovigilance and Drug Safety functions.. Lead all interactions with regulatory agencies including coordination of Pharmacovigilance/Drug Safety reports.. Minimum of ten years of experience in regulatory affairs within the biopharmaceutical industry.. Knowledge of FDA regulations and EU CTA requirements required.
They are seeking a highly accomplished and strategic Sr. Director/VP of Regulatory Affairs & Quality Assurance (RA/QA) to spearhead their regulatory and quality initiatives, with a critical focus on driving PMA and IDE submissions and bolstering their robust Quality Management System (QMS).. Develop and implement comprehensive regulatory strategies for Class III stent products, driving successful PMA and IDE submissions.. Lead the preparation, submission, and management of PMA and IDE applications, ensuring meticulous attention to detail and adherence to timelines.. Drive continuous improvement initiatives to enhance the effectiveness of the QMS.. Proven track record of successfully leading PMA and IDE submissions.
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.)
Piper Companies is currently seeking a motivated Clinical Research Associate with Oncology Clinical Trials experience to workfor a well-established clinical research organization and pharmaceutical company focused on improving the drug development process.. Candidates for this opportunity must be located in Washington.. Applications for this job will be accepted for at least 30 days from the posting date.
Vice President Regulatory Affairs. We've been engaged with a Biotech/Pharmaceutical Company in Boston for a VP. I've recently been engaged with a Biotech Company, and I'm recruiting for a VP, Head of Regulatory Affairs in the Boston Area.. Bachelor's degree in a scientific discipline; Graduate degree (Ph. D. or PharmD) strongly preferred. Minimum of 15 total years of progressive related experience in regulatory affairs in the pharmaceutical/biotech industry
Position Overview: The Regulatory Affairs Associate will support the regulatory functions for a global medical device company.. Post-Market Surveillance: Assist in the collection, evaluation, and reporting of post-market data to regulatory authorities as required (e.g., adverse event reporting, recalls, safety notices).. Support the management of vigilance systems to ensure regulatory reporting requirements are met and assist in root cause analysis for any post-market issues.. Assist in the preparation of regulatory reports to senior management on the status of filings, approvals, and market access.. Location: Baldwin, NY Job Type : Full-time Pay : $65,000.00 - $75,000.00 per year Benefits: 401(k) Dental insurance Health insurance Paid time off Vision insurance Schedule : 8 hour shift Day shift Monday to Friday Weekends as needed Application Question(s) : How many years of Regulatory Affairs do you have?
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies.. The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice.. Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness.. Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.
M3 Wake Research is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs).. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.. We are looking for a Physician - Neurologist to join our growing team.. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement and insightful market research.. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.