Healthcare & Pharma Careers

Director of Regulatory Affairs and Quality Assurance will oversee the activities of both Regulatory and Quality Assurance functions.. Review laboratory testing of raw materials, bulk product, and finished product in accordance with internal procedures and all applicable governmental regulations.. Maintain programs for documentation and technical assurance of raw material, packaging, bulk product, and finished product release specifications in addition to master batch instructions.. Develop staffing plan to manage resources needed to support any clinical trials, claim/label reviews, and regulatory reporting obligations.. Ensure supplier's chemical and microbiological testing programs (methods and sampling plans) for raw materials, packaging materials, In-process checks and finished products are adhered to, in order to guarantee product and process safety and conformance.

VARDIS is a Swiss-based oral health company founded by Dr. Haleh and Dr. Golnar Abivardi, dentists, innovators, and award-winning entrepreneurs.. At vVARDIS, we are committed to delivering innovative solutions that enhance oral health and well-being, inspired by the vision of our founders to foster preventive rather than reparative dentistry.. At the heart of our Company lies its patented, revolutionary biomimetic peptide technology.. This is a key leadership role that requires an all-rounder with deep expertise in quality management systems (QMS), regulatory compliance, supplier management, and product lifecycle oversight.. Oversee CAPA processes, change control, and risk management.

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.

Ranked #1 for Safety, Quality and Patient Satisfaction, Jupiter Medical Center is the leading destination for world-class health care in Palm Beach County and the greater Treasure Coast.. Coordinates and/or completes applications for initial submission to the Institutional Review Board (IBC) for review including assisting with protocol development activities, completing required application forms, and creating consent forms to meet JMC and sponsor standards.. and respond to Institutional Review Board requests.. Analyze and submit unanticipated adverse events (AEs) and serious adverse events (SAEs) and deviation reports to the IRB as required by sponsors and, if appropriate, make changes to the consent form to reflect new information about adverse events; provides support to internal/external staff in completing AE or SAE reports for submission to study sponsors and IRB.. Serves as information specialist and resource for regulatory, ethical and methodological questions and issues from staff.

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

About Madrigal: Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH).. Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts.

Collaborate closely with cross-functional teams, including clinical operations, clinical development, biostatistics, pharmacovigilance, and regulatory affairs, to ensure alignment between medical writing activities and program goals.. Support medical affairs to ensure alignment between publications and congress presentations and clinical documents.. Qualifications and Skills Required: 10+ years of clinical or regulatory medical writing experience supporting pharmaceutical drug development.. PhD or PharmD in Scientific Area preferred.. Strong understanding of drug development process, including clinical research, regulatory requirements, and publication strategies.

Director, Quality Assurance/Regulatory Affairs, Hoxworth Blood Center. Hoxworth Blood Center (HBC) was founded in 1938 and serves more than 30 hospitals in 18 counties in Southwestern Ohio, Northern Kentucky, and Southeastern Indiana.. In partnership with the UC Health academic healthcare system and Cincinnati Children's Hospital Medical Center, UC COM's faculty and staff are transforming the world of medicine every day.. Hoxworth Blood Center, University of Cincinnati, Division of Quality Assurance is seeking a full-time Director, to oversee and direct the coordination of quality assurance and regulatory compliance for the collection, manufacture, storage and distribution of licensed and unlicensed blood and blood components, and for the testing of donor and patient samples.. Regulatory Affairs, Quality Assurance, QA, Compliance, Quality Manager, Legal, Quality, Technology

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

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.

The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life.. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it.. Memorial Sloan Kettering's Magnet-recognized Department of Nursing is made up of almost 5,000 highly skilled nursing personnel, including more than 600 nurse practitioners, 40 clinical nurse specialists, and 32 nurse educators.. Participate in an individualized training/orientation program geared to teaching or reinforcing the principles of Clinical Trials Nursing practiced at MSKCC.. Learn More about Nursing at MSK: Our highly skilled, Magnet recognized nursing team at Memorial Sloan Kettering (MSK) comprises over 5,600 staff, including 600+ advanced practice Providers and over 70 clinical nurse specialists and nurse educators, in addition to over 100 CRNAs∯*∯ We are dedicated to delivering excellence in the art and science of professional nursing, consistent with our Vision, Mission, and Values.

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

With a newly qualified manufacturing facility and plans to scale production, we are seeking a Head of Quality Assurance and Regulatory Affairs to ensure compliance and excellence in quality and regulatory practices.. Position Overview: The Director of Quality Assurance and Regulatory Affairs will oversee the quality management system (QMS), ensure compliance with global medical device regulations, and provide strategic leadership to the quality and regulatory teams.. Qualifications: Bachelor’s degree in Engineering, Quality Management, Regulatory Affairs, or a related field; advanced degree preferred.. Strong knowledge of global medical device regulations, including FDA and ISO/CE standards.. Experience managing QMS compliance, regulatory submissions, and product lifecycle management.

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.. 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

Assess the acceptability of quality, preclinical and clinical documentation for submission filing.. Requirements: Bachelor's Degree in Science (Biology; Chemistry; Microbiology; Immunology; Medical Technology; Pharmacy; Pharmacology); Math; Engineering; or Medical fields is preferred.. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.). Individuals with "hands-on”/authoring experience with US k submission or EU MDR/IVDR technical files.. Individuals with practical experience working with in vitro diagnostics medical devices.

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