- J&J Family of Companies (West Chester, PA)
- …through their product life-cycle. + Works with design engineers, marketing, quality , supply chain, manufacturing, regulatory affairs, Health Care Professionals ... to the required activities for documents to ensure compliance with MDR; FDA Design Control regulations, and to support 510(k) submissions. + Contributes to… more
- Fujifilm (Harrisburg, PA)
- …satisfaction and/or HCUS's future business activities. + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job ... Provides on-going support to resolve application related and image quality concerns on both a product and system level....with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO… more
- Fujifilm (Harrisburg, PA)
- …satisfaction and/or HCUS's future business activities. + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job ... Provides on-going support to resolve application related and image quality concerns on both a product and system level....with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO… more
- Envista Holdings Corporation (Quakertown, PA)
- …a growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the ... + Collaboration with cross functional teams: mechanical engineering, software engineering, quality engineering, regulatory affairs. + Has developed FMEA, Risk… more
- Sumitomo Pharma (Harrisburg, PA)
- …(SmPC), and Canadian Product Monograph (PM) + Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, ... and manages Safety Charters + Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product specific and/or… more
- University of Pennsylvania (Philadelphia, PA)
- …Phase I, II, or III oncology clinical trials. + Assist the Regulatory Coordinator by preparing components of submissions (eg, institutional forms, initial ... responses to IRB stipulations, queries and concerns; remain aware of the regulatory statuses for assigned protocols. + Lead or contribute to Informed Consent… more
- Sumitomo Pharma (Harrisburg, PA)
- …(ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional teams-including clinical ... writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and contributing to… more
- Norstella (Harrisburg, PA)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... requests into structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in ensuring our… more
- Wolters Kluwer (Philadelphia, PA)
- …well understood, technically feasible, and delivered on time and with quality . * Collaborate with go-to-market teams (Marketing, Sales, Pricing, Customer Experience) ... Demonstrated success managing product line projects, including risk mitigation, regulatory awareness, translating customer needs into business requirements, stakeholder… more
- University of Pennsylvania (Philadelphia, PA)
- …regulations, GCP and IND/IDE in both adult and pediatric research. Must understand regulatory affairs and their applications to Quality Control and Quality ... Specialist (Abramson Cancer Center) Job Profile Title Clinical Research Quality Specialist C Job Description Summary The Abramson Cancer...support for inspections by external bodies such as the FDA , EMA, the NCI and CTEP. + Produced deliverables… more