- ThermoFisher Scientific (Allentown, PA)
- …Practices (GMP) Safety Standards, Office **Job Description** **Job Title: Senior Manager , Platform Engineering** Role Summary Lead development of our next-gen ... Ensure platform compliance with healthcare regulations including HIPAA, CLIA, IVDR, FDA , and GLP. + Work cross-functionally with product management, R&D, Commercial,… more
- Wolters Kluwer (Philadelphia, PA)
- The **Principal SaMD Technical Program Manager ** plays a pivotal role in driving the development and delivery of Software as a Medical Device (SaMD) products. This ... at high velocity while ensuring strict compliance with global regulatory standards such as FDA , EU MDR, ISO 13485, and IEC 62304. They are responsible for creating… more
- WK Kellogg Co (Lancaster, PA)
- …safety, customer, federal and state compliance? If so, come join us as our Manager of Quality and Food Safety in our Lancaster, PA Ready-to-Eat-Cereal Plant. In this ... of applicable regulations, GMP and food safety standards in accordance with the FDA , USDA, CFIA, etc. + Strong auditing and assessment skills. + Strong technical… more
- Globus Medical, Inc. (Audubon, PA)
- …their lives as quickly as possible. **Position Summary:** The International Sales Operations Manager will play a critical role in driving the commercial success of ... and time zones, with occasional international travel. + Familiarity with ISO, FDA , and EU MDR compliance frameworks. + Multilingual proficiency or prior experience… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... lives that makes ZOLL the ideal place to build your career.Job SummaryThe Manager of Embedded Systems Development is responsible for leading a team of hardware… more
- Edwards Lifesciences (Pittsburgh, PA)
- …SoCRA clinical coordinator/ CRA certification) + Strong understanding of ISO 14155, FDA , and international regulatory requirements + Ability to lead and mentor field ... monitors + Strong understanding of risk-based monitoring, strategies and tools to ensure compliance and data integrity + Ability to resolve conflicts and provide clear guidance + Proficiency in trial management systems (eg RAVE, CTMS, Veeva, & monitoring… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements, and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** Experience: + 8+ years of progressive… 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
- Pfizer (Collegeville, PA)
- …knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA , EMA, and global regulations. + Extensive understanding of related disciplines, ... eg, Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance. + Experience working on large data sets. + Proficiency with Microsoft Office and relevant scientific software + Effective… 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