Must have knowledge and understanding of OSHA, NFPA, The Joint Commission, EOC, FDA and other specific regulations and standards pertaining to clinical equipment service and repair. BioMed, BMET, CBET,Bio-Med, CE, Clinical Engineer, BioMedical Technician, HTM, Healthcare Technology Management, BioMedical Equipment Technician, CLES.

Ensure compliance with regulatory and accreditation requirements as applicable (e.g., TJC, ANSI, AAMI, NFPA, OSHA, CAP, AABB, CMS, FDA, FCC, HIPAA, DNV, AOA, ACR, IAC, IEC, NRC, DOH, NEC, CLIA, COLA, MQSA.

Communicates with regulatory agencies, as needed, including, but not limited to: the NYS Department of Health (DOH), Justice Center, Office of Mental Health (OMH), FDA, and others. Communicates with regulatory agencies, as needed, including, but not limited to: the NYS Department of Health (DOH), Justice Center, Office of Mental Health (OMH), FDA, and others.

Experience bringing products/systems through agency certifications: UL, FDA, CE covering safety, EMI/EMC, and medical aspects. Familiarity with Orcad, Altium, LabView and AutoCad. Familiarity with custom PCB development including footprint generation and printed circuit board layout a plus.

Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

Basic working knowledge of legal requirements and accreditation standards including The Joint Commission (TJC), Title XXII, Department of Human Services (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) organization.

Working knowledge of bioanalytical method validation and sample analysis regulatory guidelines in all regions (ICH, FDA, EMA, PMDA, ) PhD in biochemistry, molecular biology, immunology, or cell biology with minimum 8 years industry experience in biopharma development with a primary focus on the development, validation and implementation of regulated bioanalytical methods supporting clinical development.

Experience with regulatory compliance and FDA guidelines for Title 21 Code of Federal Regulations part 211 current Good Manufacturing Practices (cGMP) and Good Laboratory (Research) Practices (GCP) is desired.

The OpportunityProvide technical and analytical support for customs and trade compliance matters at the site/division level, ensuring compliance with all relevant customs regulations and trade laws and regulations, including 19CFR, 15CFR, FDA, USDA, and other US regulatory agency requirements.

Ensure compliance to all Distribution operations related to regulations, procedures and policies: ISO, SOX, USDA, Pharma (FDA), DOT, IATA/ICAO, IMDG, Bureau of Industry and Security, US Customs and customer audits.

G meat science, animal science, food science, engineering or commensurate experienceMeat and/or Seafood HACCP and/or FSPCA Preventative Controls for Human FoodGFSI scheme experience, BRC or FSSC preferred and/or SQF Practitioner or equivalentRelated Experience:Minimum 5 years’ experience in FSQ management at federally inspected USDFSIS meat and/or FDA seafood plant(s.

Our Client's FDA regulatory group works with broad range of companies, including medical devices, drugs, biologics, diagnostics, digital health, research tools, cosmetics, dietary supplements, wellness products, and other consumer products.

Currently, FDA is seeking a Project Manager/Senior Traffic Engineer for a full-time position in the Tampa office. Faller, Davis, and Associates, Inc. (FDA) has an exciting, rewarding, growth opportunity for a Senior Traffic Engineer for a full-time position in our Tampa office.

The Mammography Technologist is FDA/MQSA qualified to include meeting the MQSA CE requirements of at least 15 CEUs in a 36-month period which must include at least 6 CEUs in each mammographic modality used.

Customs entry will be filed to the PGA (PARTNER GOVERNMENT AGENCY) This will inc , FDA ,DOT ,USDA. They will need to comply to government guidelines to release the cargo. We are working with a well-established Freight Forwarder who requires a Customs Entry Writer on a full-time basis to join a growing team.