- UNC Health (Chapel Hill, NC)
- …policies and procedures. 2. Develops complex financial reports and analysis for senior management and external agencies. Presents reports to senior management ... to resolve complex problems concerning variances from approved budget. Provide technical support to assigned departments regarding budgeting system and procedures.… more
- Oracle (Raleigh, NC)
- …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
- Teleflex (Morrisville, NC)
- Senior Regulatory Affairs Specialist **Date:** Dec 2, 2025 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ... for project submissions for 510(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation , and...and ensure compliance with design controls and review design documentation to confirm regulatory requirements are met.… more
- The Clorox Company (Durham, NC)
- …**Your role at Clorox:** The Senior Regulatory Specialist will ... Cosmetics Direct). ** Documentation & Communication** + Prepare and review regulatory documentation including but not limited to ingredient assessments,… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …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 (Raleigh, NC)
- …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
- GRAIL (Durham, NC)
- …initiatives to enhance efficiency, reliability, and quality. + Prepare comprehensive technical documentation , scientific reports, and regulatory submission ... audits (internal, regulatory , or client-driven). + Excellent skills in technical documentation and scientific writing. + Demonstrated ability to collaborate… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …world of health in ways you may never have imagined in your career. The Senior Technical Manager is responsible for ensuring the latest security requirements and ... Participate in delivery of all required product security quality and regulatory documentation associated with product launches. + **Operational Management:**… more
- Oracle (Raleigh, NC)
- …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
- Grifols Shared Services North America, Inc (Clayton, NC)
- …regulatory liaison in collaborative projects with other companies + Ensures that technical documentation for regulatory submissions meets the appropriate ... cross functional teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and… more
- Fujifilm (Research Triangle Park, NC)
- **Position Overview** The Senior Manager, Quality Assurance (QA) Technical provides technical leadership and oversight for QA in a regulated pharmaceutical ... environment. This role reviews and approving Good Manufacturing Practice (GMP) documentation (eg, batch records), leads investigations and root cause analyses for… more
- Teleflex (Morrisville, NC)
- …peers to establish key risks and develop program implementation plans. * Manage Technical Documentation . * Manage Global regulatory impact assessments. * ... total cost of goods sold. The role of the Senior Regulatory Affairs Specialist is focused on...and Risk Management (ISO 14971) experience required * Excellent technical writing experience within a medical device environment -… more
- GRAIL (Durham, NC)
- …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
- Lilly (Durham, NC)
- …for US and OUS: Includes networking with Supply chain, Global Quality Leaders, Senior Management, Legal, Regulatory , Global Patient Safety, Qualified Persons at ... OUS regulatory agencies Generate, submit and maintain product shortage documentation following local procedure. + Provide information for use in various periodic… more
- Oracle (Raleigh, NC)
- …of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and recommends ... and deficiencies. + Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and… more
- Oracle (Raleigh, NC)
- …Key Responsibilities 1. Strategic Technical Leadership + Serve as the senior technical authority on designing and delivering AI/ML-powered health data ... scale. + Influence product roadmaps by representing real-world customer requirements, regulatory constraints, and innovation opportunities to senior product and… more
- Parexel (Raleigh, NC)
- …regulations. + Broad experience in preparation of all types of clinical regulatory documentation . Experience in management of complex medical writing projects. ... The Senior Medical Writer also facilitates process improvement and technical mentoring/training and supports Medical Writing Services management during the sales… more
- Capital One (Raleigh, NC)
- …teams to ensure our security responses are accurate and reflect our latest technical and regulatory standing. + RFI/RFP Response: Analyze and respond to ... + At least 4 years in customer-facingroles, acting as a trusted advisor to senior security and IT leaders. + Deep technical understanding of cybersecurity… more
- Oracle (Raleigh, NC)
- …and audit readiness. + Prepare and maintain detailed incident records, technical documentation , post-mortem analyses, and operational runbooks. + Collaborate ... **Job Description** ** Senior Network Development Engineer** **MUST BE A US...audits as required. + Maintain, organize, and update detailed technical documentation , including network diagrams, incident records,… more
- City of Durham (Durham, NC)
- …and supports continuous improvement of governance frameworks. + Reviews project documentation , technical specifications, and vendor materials to identify ... workflows, and data-lifecycle management. + Experience preparing analytical reports, technical recommendations, or policy documentation for operational or… more
