- UpvoteDownvoteShare Job
- Suggest Revision
The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
ExpandUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
This includes developing, implementing, enforcement and documentation for all prerequisite programs related to all production, sanitation, and pest control activities for HACCP, USDA, FDA, and SQF/ BRC related programs.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Support cross-functional new product development projects and lead compilation of all materials required for submissions to FDA. Keep abreast of FDA guidance documents and regulations and monitor impact of changing regulations on submission strategies.
ExpandUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
This includes plant quality system compliance with FDA, GMP, HACCP, SQF, Sanitation, Organic and Kosher. Examples of contacts are: MMDS, EPA, USDA, FDA, City and County officials, and OSHA.
Full-timeExpandUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Familiarity with GLP, OSHA guidelines, FDA, BAM, APHA, ISO, and USP methods and procedures. Certified Group includes Food Safety Net Services (FSNS), Certified Laboratories, EAS Consulting Group, Labstat International Inc., Advanced Botanical Consulting & Testing (ABC Testing Inc.), Microconsult Inc., and Micro Quality Labs Inc. Certified Group provides laboratory testing and regulatory consulting services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, tobacco, nicotine, cannabis, hemp, and other industries.
ExpandUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Designated an FDA Breakthrough Device for lung tumors, RefleXion's SCINTIX biology-guided radiotherapy aims to overcome long-standing barriers preventing definitive radiotherapy for metastatic disease.
Full-timeExpandUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
We expect our employees to comply with all relevant FDA requirements and external certifications (e.g. Kosher, Halal, etc.) This person will be working on groundbreaking fermentation in this next generation of plant-based food products.
ExpandUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Experience with healthcare regulation, including: fraud and abuse (e.g., anti-kickback); FDA for medical devices; data use and privacy (e.g., HIPAA, GDPR); and anti-corruption (e.g., FCPA). Experience with healthcare regulation, including: fraud and abuse (e.g., anti-kickback); FDA for medical devices; data use and privacy (e.g., HIPAA, GDPR); and anti-corruption (e.g., FCPA.
RemoteExpandUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
We are currently looking for a Pathogen Lab Analyst to join our growing team! Assist in quality duties to by taking incubator temperatures, inoculating control organisms, running media controls, etc.
ExpandUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Keeps abreast of and ensures compliance with regulatory practices (e.g. FDA, EMA, and ICH guidance and recommendations) and industry data standards (e.g. CDISC). The Head of Biopharma Biostatistics serves as a leader within the global biostatistics department responsible for strategic and operational oversight of the biostatistics and statistical programming activities for Emmes biopharma portfolio in key therapeutic areas such as vaccine and infectious diseases, ophthalmology, CNS, rare disease and cell and gene therapy among others.
ExpandUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Maintain a current knowledge of applicable phase appropriate FDA and International cGMP regulations for Regenerative Medicine, Cell Therapy, and Good Tissue Practices. Overview The Quality Assurance (QA) Auditor provides compliance and quality improvement support to the manufacture of phase 1/2a Investigational New Drug, Biologics manufacture and facility operations.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Solid understanding of regulations for HTS (Harmonized Tariff Codes), U.S CBP (Customs Border Protection), FDA (Food & Drug Administration), OGA (Other Government Agency) clearances, and Federal & International Hazardous Material Regulations.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
E.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. Extensive working knowledge of FDA regulations, FDA guidance and ICH guidance; some familiarity exposure to EMEA regulations.
ExpandUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Responsible for successful delivery of biostatistics and statistical programming services to Emmes biopharma clients overseeing budget, timelines, and quality of biostatistics related deliverables. Effectively supervises biostatistics and statistical programming staff providing mentorship, feedback and conducting performance reviews.
ExpandUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The Senior Manager, Quality Assurance will be responsible for establishing and maintaining quality processes and improvement initiatives for FDA and ISO-regulated products and clinical testing, specifically supporting Foresight’s GCP/CLIA laboratory.
ExpandUpdated Today
fda job
FEATURED BLOG POSTS
What is a W-9 and How to Fill One Out
When you began working for yourself, you probably didn’t account for the tax reporting work that will fall on your shoulders each year. If you’re a freelancer, independent contractor, or business owner, filing your taxes is not as simple as uploading your W-2 form into some online tax preparation software. Most self-employed people need to complete a W-9 as a step for accurately reporting their earnings to the IRS. Below, you can learn how to fill out a W-9 and when to submit it.
Tightening the HR budget in 2023
With the state of the economy still uncertain, 2023 is expected to be approached with much anticipation. Human Resource leaders have many concerns, including how they will manage to accomplish their goals with budget belts already getting snug. Let’s look at some of the factors that the new year is projected to bring for HR and how to prioritize budgets to reach human capital objectives.
A Comprehensive Guide to Becoming a Better Conversationalist
Have you ever stood awkwardly next to someone at a party because you didn’t know what to say to them? How about at a networking event or on a first date? You're not alone if you’ve ever experienced this uncomfortable silence. Many people struggle to master the art of being a great conversationalist.
Why is Non-Verbal Communication Really Important?
In a world where words and phrases rule daily communication, you may wonder why non-verbal communication is important. Whether you realize it or not, you communicate more with nonverbal actions than you do with verbal communication. When you interact with your peers, people are reading your body language, facial expressions, voice, and many other factors that help fill in blanks that words can't fill.
Making Hybrid Work More Efficient
Covid was a catalyst for change in the work environment. Keeping people safe and helathy was the initial goal for employers, but the unintended result was the considerable demand in remote work. Now, onsite work has been dramatically altered to remote work, which is now transforming into a combination of the two: hybrid work.
How Can HR Technology Help Retain Employees?
Human resources' rapid adoption of technology has led to new ways of streamlining human capital management. Based on the IEE Global Study, these technologies changed how HR handled recruitment and retention in 2022. This includes tech like
Why is Time Management Important? 10 Crucial Importances of Time Management
We’ve all been there before. What starts as a relaxing evening scroll quickly becomes a full-blown binge. You blink, and it’s midnight - throwing off your entire next day before it even starts. And at its worst, this indulgence might leave you feeling behind on things you planned to finish that night. This is why time management is important.