- Terumo Neuro (Aliso Viejo, CA)
- …Supports preparation and hosting activities for third party audits including FDA , Notified Body, corporate and international regulatory authorities' audits. Supports ... multiple projects concurrently, have computer experience and have knowledge of FDA Regulations and Application of Good Manufacturing Practices. 4. Demonstrates… more
- AbbVie (North Chicago, IL)
- …for US and foreign patent prosecution, listing patents in the FDA 's Orange Book, analyzing freedom-to-operate issues, addressing contractual issues, evaluating ... on a broad range of matters involving the Food and Drug Administration ( FDA ), Federal Trade Commission (FTC), Office of Inspector General (OIG), and other applicable… more
- Abbott (Sylmar, CA)
- …and process development from concept through sustained manufacturing of FDA regulated products. Responsible for production support, maintenance support, performing ... regulatory requirements. *Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more
- Danaher Corporation (New York, NY)
- …product development through a stage gate process and applicable knowledge of US FDA and International regulations. + Experience working in a corporate, global or ... regional marketing role involving diagnostic or medical device products/services. + Exposure to P&L responsibility, and the related financial acumen needed to drive business decisions and outcomes. + Demonstrated exceptional interpersonal and communication… more
- ManpowerGroup (Milpitas, CA)
- …facilities management experience, with at least 5 years in pharmaceutical or FDA -regulated environments. + HVAC certification such as NATE or equivalent, and ... electrical licensing or certification. + Experience with validated systems, GMP, GLP, and GCP regulations. + Proven leadership skills managing multidisciplinary teams and vendor relationships. **What's in it for me?** + Opportunity to work in a critical role… more
- Stryker (Portage, MI)
- …industries) regulations and standards related to product safety, including FDA and international requirements. Health benefits include: Medical and prescription ... drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings… more
- BioLife Plasma Services (Snellville, GA)
- …(in state of licensure) for basic IV therapy Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist Two years in ... a clinical or hospital setting **What Takeda can offer you: ** Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose… more
- ADM (Erlanger, KY)
- …to ensure that all rules and regulations set forth by the US Customs & FDA are in place and being followed in regards to compliance related activates. Additionally ... responsible for researching and implementing processes as required to meet all company and departmental goals and objectives. To ensure global supply chain is minimally affected and be proactive with identifying risk to the supply chain. **Responsibilities and… more
- Cordis (Irvine, CA)
- …Proficiency in MS Office applications (Word, Excel, Outlook). + Knowledge of ISO 13485, FDA 21 CFR Part 820, or similar quality system standards. + Fluent in English ... **Preferred Qualifications:** + 3+ years of document and change control experience in the regulated environment. + 3+ years of relevant experience in the Medical Device Industry. **Key Competencies** + Precise, rigorous, and detail-oriented approach to… more
- United Therapeutics (UT)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an… more
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