- DHL Express, Inc. (Erlanger, KY)
- …management skills + Process shipments through various online portals for submission to FDA and US Customs to obtain proper clearance **Skills & Qualifications:** + ... High School Diploma or Equivalent (Associate degree preferred) + Overtime is required + 1 year experience in transportation or customs preferred + Proficiency with Microsoft Office (Word, Excel, Outlook), database and web-based applications + Good oral and… more
- DHL Express, Inc. (Erlanger, KY)
- …+ Participates in processing inbound freight for clearance through US Customs + Effectively processes shipments to gain clearance information while staying compliant ... **What makes DHL great?** Our People! We know each employee's individual contributions make us the #1 Delivery and Logistics Company in the world. **_Distinguished as No. 1 World's Best Workplace by Great Place to Work and Fortune Magazine_** DHL is committed… more
- ITG Brands (Greensboro, NC)
- …of Premarket Tobacco Product Applications (PMTAs) and other regulatory filings to the FDA Center for Tobacco Products (CTP). The ideal candidate will hold a PhD ... discipline and possess deep expertise in regulatory strategy, toxicology, clinical studies, and FDA engagement. - WHAT YOU WILL DO + Lead the strategic planning,… more
- Lundbeck (Deerfield, IL)
- …managing end-to-end process of promotional material inventory, fulfillment, and compliance, FDA 2253 submissions and field operations day to day support. The ... role ensures timely and accurate submission of promotional materials to the FDA 's Office of Prescription Drug Promotion (OPDP).The specialist will also coordinate… more
- Caris Life Sciences (Phoenix, AZ)
- …across laboratory, operational, and customer-facing functions to maintain compliance with FDA , ISO 13485, CAP, and CLIA requirements while driving data-informed ... Caris' global Quality System and Regulatory framework, maintaining compliance with applicable FDA , ISO 13485, CAP, and CLIA standards. The analyst contributes to… more
- Terumo Medical Corporation (Elkton, MD)
- …Device Reporting (MDR) to US and global health authorities (GHA) such as FDA , HC, MHRA, etc. The Adverse Event Reporting Team is responsible with implementation ... role) 12. Assist with third party/regulatory audits (Customer, Notified Body, FDA ) 13. Monitor and remain current with internal company procedures/policies,… more
- Caris Life Sciences (Phoenix, AZ)
- …across laboratory, operational, and customer-facing functions to maintain compliance with FDA , ISO 13485, CAP, and CLIA standards while driving proactive ... in alignment with Caris' Quality System procedures and applicable external requirements ( FDA 21 CFR, ISO 13485, CAP/CLIA, PMDA, CMDCAS, and other global regulatory… more
- BeOne Medicines (Pennington, NJ)
- …and release of material, intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne processes and procedures. ... working experience and 2 years managing laboratory analysts in an FDA -regulated biotechnology, pharmaceutical company with progressive levels of responsibility are… more
- BeOne Medicines (Emeryville, CA)
- …will interface with outside regulatory agencies and more specifically, the FDA , and business partners regarding development, regulatory, and registration strategies ... risk assessments, critical issue management and advice for the FDA and Health Canada interactions. + Uses extensive knowledge...local regulatory requirements + Liaises and negotiates with the FDA and Health Canada as needed for all aspects… more
- WuXi AppTec (Middletown, DE)
- …of User Requirements Specifications. + Ensuring compliance with regulatory requirements ( FDA , EMA, cGMP), quality standards, and safety regulations. + Conducting ... drawings, and functional specifications. + Thorough understanding of cGMP and FDA requirements + Strong communication and documentation skills + Proven project… more
- Endo International (Raleigh, NC)
- …ensuring compliance with Good Manufacturing Practices (GMP) and applicable regulations ( FDA , EMA, ICH). This individual will provide overall QC leadership regarding ... to ensure they meet specifications.** + **Ensure adherence to FDA , EMA, and other regulatory standards, including PIC/S GMP...of change, and achievement of results** + **Contact with FDA as subject matter expert during site inspections and… more
- Endo International (St. Louis, MO)
- …of manufacturing sites in the area of Quality Systems, and Training. + Interfaces with FDA and regulatory agencies outsite the US for events that include but are not ... results from direct and indirect reports. + Knowledge of FDA and International regulations and guidances in the area...+ Experience interacting with regulatory agencies such as the FDA and EU regulatory bodies as an inspection host.… more
- embecta (Parsippany, NJ)
- …strategies. + Coordinate, prepare, and complete premarket applications to the US FDA , including 510(k) submissions, in a timely manner. + Assess necessity for ... ensure compliance with applicable laws, regulations, and company policies. + Ensure FDA product listings and facility registrations are submitted and maintained. +… more
- Endo International (Rochester, MI)
- …in a body of information required for the job_ _e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc._ + Has strong knowledge of ... knowledge of applicable safety and standards guidelines, such as FDA , ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS...levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of… more
- Integra LifeSciences (Princeton, NJ)
- …in compliance with US and International requirements as defined in FDA Regulations, ISO Standards, European Medical Device Directives, and other International ... quality document control and training processes meet the industry standards outlined by FDA 21CFR 820 and ISO 13485 + Effectively identify, prioritize and manage… more
- Terumo Medical Corporation (Elkton, MD)
- …be to support product development prototype evaluations, or could be submitted to the FDA to support new product clearance or claims. 10. Performs other job related ... cross-functional interactions needed for the development of new products within FDA design control guidelines. o Demonstrated understanding of cardiology and… more
- ITG Brands (Greensboro, NC)
- …and nicotine products. The ideal candidate will bring deep expertise in FDA regulation, multi-state compliance, and regulatory litigation, with the ability to ... and nicotine products. Serve as a strategic legal advisor on FDA regulatory matters, including product submissions, labeling, marketing, enforcement, and reporting.… more
- Teleflex (Wyomissing, PA)
- …NC resolutions, and audit preparation activities in support of quality system requirements (eg, FDA 21 CFR Part 820, ISO 13485, ISO 17025). - Manage and execute ... and validation. - Demonstrated experience working within quality-regulated environments ( FDA , ISO standards) in medical device, biotech, or pharmaceutical… more
- Curia (Rensselaer, NY)
- …compliance with all Quality Management Systems and Regulatory Agency requirements (eg, FDA , EMA, MHRA, etc..) for the Rensselaer site. + Conduct investigations of ... industry (preferred in APIs) at USFDA regulated facilities + Broad knowledge of cGMP, FDA and international regulations (eg, 21 CFR 11, 210, 211, 820, EU GMP, ICH… more
- CSL Behring (King Of Prussia, PA)
- …releases) for consistency with local and international regulatory requirements (eg, FDA , EMA, PMDA). - **Regulatory Authority Interaction:** Serve as the primary ... bodies on advertising and promotion matters, including submission of materials to FDA OPDP or APLB, responding to inquiries, and managing enforcement risk. -… more
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