- Deloitte (Pittsburgh, PA)
- …a digitally enabled, equitable future of health. Work You'll Do As a Manager you will lead and deliver engagements, or components of large, complex engagements. ... familiarity with ICH guidelines (ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA /EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND,… more
- Nammo Defense Systems, Inc (Scranton, PA)
- …Nammo Pocal is looking for an experienced and results-driven Quality Control Manager / ISO Management Representative with 5+ years of leadership experience in ... and time management skills * Familiar with Military Specifications or equivalent (pharmaceutical, FDA , etc.) * Familiar with ISO 9001-2015 * Ability to Read and… more
- ZOLL Medical Corporation (Philadelphia, PA)
- …sleep disorders. Our core product is the WatchPAT(R)️ family, a revolutionary FDA -cleared portable home sleep apnea test device, that is based on proprietary ... signal and analysis. 80% of patients who have sleep apnea are undiagnosed. We are committed to reach those undiagnosed patients and provide testing to promote wellness and enhance overall quality of life. WatchPAT(R)️ is commercially available within major… more
- United Therapeutics (Harrisburg, PA)
- …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
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …organizations. **Knowledge, skills, & abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of ... global regulatory regulations. Excellent oral and written communication skills. Critical thinking and problem solving skills. Demonstrated project management skills. Ability to interact with regulatory officials. Ability to evaluate complex issues and meet… more
- Sumitomo Pharma (Harrisburg, PA)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... marketed products. The base salary range for this role is $127,920 to $159,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our… more
- Globus Medical, Inc. (Audubon, PA)
- …several stages of development (ie existing portfolio, near-term launch, pending FDA approval and new products). Supports product lifecycle management, product ... roadmap, technique, new product training and product launch readiness with revenue goals in mind. **Essential Functions:** + Keeps a strong pulse on the market by attending trade shows, VIP surgeon events, spine surgeries and labs + Collaborates with upstream… more
- Sysco (Harmony, PA)
- …Complies with local, state and federal regulatory agencies (ie OSHA, AIB, FDA , USDA, etc.) **QUALIFICATIONS** **Education** + High school diploma or general ... education degree (GED). + 2 or 4-year college degree in Business Management, Supply Chain Management or similar major preferred. **Experience** 3-5 years related experience and/or training; or equivalent combination of education and related experience.… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …and literature reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ISO13485, ... ability to maintain quality documents to ensure compliance with FDA regulations and guidance documents relating to these areas...initiates new or special assignments with occasional direction from Manager . Must have ability to work in a team… more
- Globus Medical, Inc. (Audubon, PA)
- …submissions, and approval for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This position entails development of ... FDA submissions, requires working knowledge of products under review...Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for… more