...engineers.
Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies.
Understands and is aware of the quality consequences which may occur from the improper performance...
Suggested
Contract work
Local area
...patient contact as needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Principal Responsibilities:
Works...
Suggested
Work experience placement
Local area
Shift work
...provide our global customers with affordable, high-performance products and industry-leading excellent service. Argen’s products are FDA regulated and ISO certified.
About the Opportunity
The Senior Commercial Business Analyst leads and drives a culture of analytical...
Suggested
Holiday work
For contractors
Monday to Friday
...regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities
Independent study coordination including screening...
Suggested
Local area
Shift work
...identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities
Independent study coordination including...
Suggested
Local area
Shift work
...team members
Knowledge, Skills, and Abilities:
Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations
Knowledge of genetic conditions including Down syndrome
Knowledge of ICH Guidelines regarding development phases,...
Suggested
Work experience placement
Local area
...safe practices
Demonstrates commitment to complete work in accordance with our Quality Management System supporting ISO requirements FDA regulations, and those put forth by other regulatory agencies.
Understands and is aware of the quality consequences and device...
Suggested
Contract work
Temporary work
Work experience placement
Local area
...overcome technical challenges. Leads teams of research personnel in the execution of R&D projects,
Participates in the preparation of FDA filings to support clinical translation and maintain interactions with external partners at universities and companies.
Designs...
Suggested
For contractors
Remote job
...provides our global customers with affordable, high-performance products and industry-leading customer service. Argen’s products are FDA regulated and ISO certified.
About the Opportunity
A Manufacturing Associate I produces standard and/or custom medical devices...
Suggested
Holiday work
For contractors
Monday to Friday
...people involved and building a network of contacts that allow you to multiply your influence on the organization.
* Knowledge of DOT, FDA, and OSHA regulations
Computer Skills
* Proficient in Microsoft Office Suite
Language Skills
* English (reading, writing,...
Suggested
Local area
Outdoor
Night shift
...public health and safety measures, EXOS requires that all successful applicants shall be required to show proof of full vaccination by an FDA-approved COVID-19 vaccine before beginning employment, unless an exemption from this policy has been granted as an accommodation or...
Suggested
Local area
Worldwide
...Systems (QMS), Environmental Health Systems (EHS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains...
Suggested
Contract work
For contractors
Remote job
Shift work
...capabilities. The company’s more than 60,000 employees serve clients in over 100 countries, worked on over 80% of the new drugs approved by the FDA in 2022 and performed more than 600 million tests for patients around the world
Global Internship Program:
Exciting...
Suggested
Full time
Part time
Internship
Flexible hours
Monday to Friday
...centers, Greenbrook is a leading provider of Transcranial Magnetic Stimulation ("TMS") therapy and Spravato® (esketamine nasal spray), FDA-cleared, non-invasive therapies for the treatment of Major Depressive Disorder ("MDD") and other mental health disorders, in the...
Suggested
Full time
Local area
Night shift
Weekend work
...Description
Job Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to...
Suggested
...Description
Job Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to...
...provide our global customers with affordable, high-performance products and industry-leading excellent service. Argen’s products are FDA regulated and ISO certified.
About the Opportunity
The Director of Marketing leads and oversees all marketing efforts from...
For contractors
Monday to Friday
...of 1 year of experience with PharmaSuite MES solutions in a highly automated Life Sciences manufacturing environment
* Knowledge of FDA and GMP guidelines
* Bachelor's Degree or equivalent (minimum 3 years work experience). If Associate's Degree, must have equivalent...
Work experience placement
Local area
...biology, chemistry, or a related field.
2+ years of experience in regulatory affairs in the biotechnology industry.
Knowledge of FDA regulations, including 21 CFR, 510(k), and PMA requirements.
Strong organizational and project management skills.
Excellent...
...years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role
Professional working knowledge of FDA regulations and ICH/GCP guidelines
3+ years of prior clinical experience conducting routine procedures (e.g. V/S, EKG, phlebotomy)...
Remote job
Flexible hours
...consider candidates who require sponsorship for a work-authorized visa.
* You've acquired a minimum of 4+ years' experience working in FDA regulated Medical Device Clinical Study environments, with a focus on Clinical study execution, policies, and procedures.
* You...
Work visa
...research site-based experience
Minimum 4 years of experience in managing Phase 1-3 global clinical trials
Strong knowledge of FDA regulations and GCP/ICH guidelines, and knowledge of regulatory requirements regarding clinical trial management
Strong experience...
Holiday work
Full time
Temporary work
Local area
Flexible hours
Monday to Friday
...equivalent Exact specific experience.
~ Demonstrated practical working knowledge of global IVD regulations and quality standards; including FDA QSR, ISO 13485, IVDD, IVDR, and others relevant to molecular diagnostics.
~ Strong understanding of the Quality System Regulations...
Local area
Remote job
Worldwide
Night shift
...D printing and milling machines and operates six days a week. Argen’s products are held to the highest standards of quality, and are FDA 510(k) cleared, ISO 13485 certified, and MDSAP compliant. Argen embodies a culture of innovation, continuous improvement, and LEAN practices...
Holiday work
For contractors
Worldwide
Monday to Friday
...D printing and milling machines and operates six days a week. Argen's products are held to the highest standards of quality, and are FDA 510(k) cleared, ISO 13485 certified, and MDSAP compliant. Argen embodies a culture of innovation, continuous improvement, and LEAN practices...
Holiday work
For contractors
For subcontractor
Local area
Worldwide
Monday to Friday
...preferred.
Ability to multitask and proactively utilize critical thinking skills
Ability to work in a regulated environment (GMP/FDA/DEA/OSHA) and strictly follow procedures.
Ability to read, write, and comprehend reports, technical and cGMP documents as well as...
Holiday work
Work experience placement
Local area
Worldwide
Relocation package
Currently hiring
Day shift
Monday to Friday
...treatments for patients with under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, as well as clinical programs...
Holiday work
...submissions in a format consistent with applicable guidance documents
Prepare and manage Q-submissions for timely responses from the FDA
Assist in regulatory submissions (510(k), PMA, and CE)
Prepare and manage e-STAR regulatory submission requirements
Maintain...
Flexible hours
...Understanding of coagulation-based manufacturing processes and company products.
Familiarity with GDP, GMP, Good Laboratory Practices (GLP), FDA, and ISO.
Working knowledge of Microsoft Office and large Enterprise Resources Planning (ERP) systems is preferred.
Benefits...
Temporary work
Local area
Immediate start
Worldwide
Rotating shift
Afternoon shift
...Fire Protection Specialist (CFPS)
HPR Property experience
Capable of navigating and understanding regulatory requirements such as FDA, EPA, OSHA, NFPA, etc.
Industry experience in manufacturing, life science, or technology sectors.
Account oversight experience...
Full time
Temporary work
Apprenticeship
Local area
Remote job
Work from home
Visa sponsorship
