- Oracle (Harrisburg, PA)
- …AI-enabled population health platform. To support these efforts, we are hiring ** Regulatory Technical Documentation Engineers** with **deep engineering ... documentation + Experience preparing documentation for audits, technical files, or regulatory submissions. **Preferred** + Experience in healthcare,… more
- West Pharmaceutical Services (Exton, PA)
- …for regulatory issues and questions. + Compile and maintain regulatory documentation databases or systems as well as technical documentation required ... Senior Regulatory Affairs Specialist Requisition ID:...Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …post-approval supplements). Determine regulatory CMC content and scientific/ technical requirements to ensure documentation meets regulatory ... Global Regulatory Strategy). + Assess and provide regulatory strategy for CMC technical changes, process...Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions. Develop… more
- Oracle (Harrisburg, PA)
- …leadership, presenting data-driven recommendations and guiding cross-functional alignment. + ** Technical Documentation :** Help lead the efforts across both ... and compliance activities** as HDI expands globally. Ensure operational processes and documentation align with regulatory standards and help drive readiness for… more
- Oracle (Harrisburg, PA)
- …and ability to summarize complex trade-offs and options in presentation and technical documentation . + Ability to effectively represent engineering perspectives ... and working on ambitious new initiatives. A TPM at any level can have significant technical and business impact here. You will be part of a team of hard-working,… more
- PNC (PA)
- …complex business needs. + Writes code, tests and deploys software. + Prepares technical and procedural documentation required for software. + Maintains and ... Application Testing, Packaged Application Integration, System Development Life Cycle, Technical Troubleshooting, Technical Writing/ Documentation **Work… more
- Guardian Life (Bethlehem, PA)
- …efficient operation of our Group Underwriting organization. As the Group Underwriting Senior Technical Writer in Group Benefits Underwriting, you will ... and IT to gather source material and validate content. + Familiarity with regulatory standards and documentation practices in insurance. **You have:** +… more
- Teleflex (Wyomissing, PA)
- …markets. * Update and maintain EU MDR technical files and documentation to ensure continued compliance. * Support regulatory compliance activities, including ... or equivalent. * Basic experience with preparing 510(k) submissions, EU MDR Technical Documentation Files, or Health Canada license applications. * Basic… more
- GRAIL (Harrisburg, PA)
- …to project teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as ... Test (LDT) products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor… more
- Talen Energy (Berwick, PA)
- … regulatory advice and interpretations of Licensing documents, eg Technical Specifications, 50.59 requirements, Inspection Procedures. + Interact with NRC ... + Ensures problems are being identified and resolved. + Reviews design documentation to determine compliance with Licensing basis criteria or standards. + Schedules… more
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