...thoroughly familiar with GMP regulations for the life sciences industry. We are currently looking for someone who used to work for the FDA and/or has extensive experience with mock FDA Audits.
As an SQA Quality Auditor, you will have at least four years’ experience and...
Suggested
Local area
...Research Specialist Position Duties:
Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA) Office for Human Research Protections (OHRP) Good Clinical Practices (GCP) Institutional Review Board (IRB) HIPAA regulations and institutional...
Suggested
Flexible hours
..., sampling, and storage of plasma collected from donors. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.
**Key Accountabilities**
1. Follows all Standard Operating Procedures (SOPs) and regulatory policies and procedures,...
Suggested
Holiday work
Immediate start
Flexible hours
...spelling; language and style consistency; accuracy; sense/clarity; required copy
Ensures relevant standards (eg, client/brand, AMA, FDA) are met
Is knowledgeable of and remains current on FDA guidelines
Creates and maintains editorial style sheets for each...
Suggested
Remote job
...DUTIES & RESPONSIBILITIES
Completing DMCR-required training, including GCP and IATA.
Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.
Maintaining a current, up-to-date...
Suggested
...Supports the safety of clinical research procedures, study visits, and follow-up care
Submits documents to regulatory authorities (IRB, FDA, etc.) and/or review/monitoring boards
Facilitates study close out activities
Retains records and archives documents after...
Suggested
Holiday work
Flexible hours
Monday to Friday
...filing expense account reports, scheduling appointments, and making travel plans.
+ Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
+ Maintains...
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For contractors
Work experience placement
Weekend work
...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
Work experience placement
Local area
Remote job
Worldwide
Flexible hours
...public relations, web-based activities, newsletters and social media outlets.
A strong working knowledge of GCP, ICH, DHHS, OIG and FDA regulations and depth of clinical expertise in the assigned area is required along with familiarity of all applicable federal and...
Suggested
Contract work
Local area
...agencies and scientific conferences. The ideal candidate will have a deep understanding of human subject research, ICH/GCP guidelines, and FDA/CMS/LDT regulations, and will be a strategic thinker with the ability to execute clinical strategies effectively.
Hiring Manager...
Suggested
...experience in public markets, M&A, debt and equity financing, and regulatory product experience, with a preference for those familiar with FDA-regulated companies and international law.
The successful candidate for the General Counsel position at the company will be an...
Suggested
...including, but not limited to, The Joint Commission (TJC), National Fire Protection Association (NFPA), Food and Drug Administration (FDA), Nuclear Regulatory Commission (NRC), Association for the Advancement of Medical Instrumentation (AAMI).
+ Documents all work...
Suggested
Contract work
Local area
Remote job
Relocation
Shift work
Monday to Friday
...standards in the operations of clinical research. Requires subject matter expertise and demonstrated working knowledge of ICH, HHS, and FDA regulations pertaining to the ethical conduct of research. Responsibilities include daily operational guidance to all SJHMC/BNI...
Suggested
Local area
...Responsibilities will vary based on the needs of the research as well as the participant needs in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Good Clinical Practices (GCP), Institutional Review Board (IRB), HIPAA regulations...
Suggested
...global leader in diagnostic imaging.
About the Role:
The Regional Sales Manager is responsible for sales activities related to FDA approved, commercialized Blue Earth Diagnostics products within an assigned geography. The ideal candidate is responsible for promoting...
Suggested
Holiday work
Local area
Remote job
...authorities, including experience with regulatory submissions, is a key requirement. The candidate must have extensive knowledge of GCP, ICH, FDA, EMA, CDISC standards, and a proven track record in statistical techniques and data science methodologies. Strong programming skills...
...Preferred Certifications: PMP, Lean Six Sigma
8-12 years of experience in engineering project management preferred
Experience with GMP and FDA regulations in medical device industry preferred
Must possess strong analytical skills to evaluate complex technical information
Must...
Contract work
Temporary work
Local area
Flexible hours
...appropriate regulatory strategies for product clearance.
**RESPONSIBILITIES**
+ Participate in the planning of meetings between the FDA and CMSU regarding regulatory issues as assigned by the Director, Regulatory Affairs.
+ Provide guidance to CMSC Business Unit...
Remote job
...new US employees joining our company. Fully vaccinated persons are those who are =14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine. If you are applying to a sales and field role which requires access to customer accounts as a function...
Full time
For contractors
Relocation
...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...
Local area
Remote job
Worldwide
...various pharmacy practice settings.
General Pharmacy Technician Duties: Practice within all State Board of Pharmacy, DEA, and FDA rules and regulations Preparation of prescription orders Preparation includes sterile and non-sterile preparation (hazardous and...
Full time
Part time
Immediate start
Relocation bonus
Shift work
Night shift
...President, Clinical Development will be responsible for leading critical clinical research initiatives and directing engagement with NIH, FDA, and key industry stakeholders while influencing the the development of clinically meaningful outcome measures.
Travel Percent...
...approving dietitian for the menus.
* Assures compliance with all regulatory agency requirements (i.e. The Joint Commission (T JC), FDA Food Code and VHA directives and guidelines.
* Keeps section 'inspection ready' at all times.
* Provides administrative direction...
Permanent employment
Internship
Remote job
Relocation
Monday to Friday
...responsible for leading critical clinical research initiatives for a globally recognized foundation and directing engagement with NIH, FDA, and key industry stakeholders.
Travel Percent
Less than 10%
Functions
~ Medical Care/Hospital Administration
Known...
...devices
machine learning
Artificial Intelligence
physical therapy
virtual physical therapy
digital physical therapy
fda-listed device
biofeedback
MSK
musculoskeletal
and telemedicine
About the Role
The Vice President, People Operations...
Remote job
...inspections of molded components.
Duties - cont'd
Follows the company's medical manufacturing quality system per ISO 13485 and FDA guidelines to insure product quality meets or exceeds customer expectations.
Adheres to company safety policies as well as OSHA...
Hourly pay
Holiday work
For contractors
Local area
Relocation bonus
Shift work
Saturday
Afternoon shift
Monday to Friday
All shifts
...Medicine, General Orthopedics, Trauma, Dental, and Regenerative Medicine. Pinnacle is registered with the Food and Drug Administration (FDA) and accredited by the American Association of Tissue Banks (AATB)
How You Contribute to Pinnacle Transplant’s Success
The...
Holiday work
Full time
Temporary work
For contractors
Shift work
Night shift
Sunday
Afternoon shift
...patient visits. You will be responsible for independently conducting complex interventional & therapeutic protocols in compliance with FDA regulations and ICH-GCP guidelines. You may coordinate at each of our 5+ offices we work in throughout the Phoenix valley.
~...
Private practice
Local area
Flexible hours
...Director at Medivant Healthcare, you will play a pivotal role in developing and implementing strategic marketing initiatives to promote our FDA shortlisted drugs to hospitals and clinics. You will lead a dynamic team and work closely with cross-functional departments to drive...
Full time
Relocation
Monday to Friday
...skills to grow as a Clinical Research Coordinator in order to conduct complex interventional & therapeutic protocols in compliance with FDA regulations and ICH-GCP guidelines.
How to conduct patient acquisition to meet and exceed enrollment goals.
How to cultivate a...
Private practice
Flexible hours