- Teleflex (Morrisville, NC)
- …full responsibility for project submissions for 510(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation , and Canadian license ... The SRA will assist in mentoring and development of Regulatory Specialists as part of the role. ** Principal...and ensure compliance with design controls and review design documentation to confirm regulatory requirements are met.… more
- Teleflex (Morrisville, NC)
- …- Experience using tools for change management - Experience producing technical documentation including functional requirements, design specifications, work ... implemented or existing systems and processes according to quality, compliance, and regulatory requirements - Identify and address technical or operational risks… more
- Teleflex (Morrisville, NC)
- …written communication skills; able to communicate across technical and non- technical teams. - Strong analytical, problem-solving, and documentation skills. - ... difference in patients' lives. **Position Summary** Lead and coordinate the technical activities related to the development, implementation, and sustaining of Arrow… more
- Teleflex (Morrisville, NC)
- …and embedded software systems. This role involves providing strategic cross-functional technical leadership to ensure alignment with best practices and frameworks ... excellence and achieving reliable and predictable software market releases. ** Principal Responsibilities** 1. Designs, develops, verifies, and maintains medical… 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
- Oracle (Raleigh, NC)
- **Job Description** Oracle Health Data Intelligence (HDI) is hiring a Principal Technical Program Manager - Operations to lead key strategic and operational ... leadership, presenting data-driven recommendations and guiding cross-functional alignment. + ** Technical Documentation :** Help lead the efforts across both… more
- Oracle (Raleigh, NC)
- …development lifecycle, enabling teams to maintain compliance through automated traceability and documentation . + Support audits, technical documentation , and ... **Job Description** As a Principal Member of Technical Staff, you...and relevant FDA guidance. + Proven ability to apply regulatory requirements to software design, documentation , and… more
- Fujifilm (Raleigh, NC)
- …written documentation , periodic review, and Intranet postings + Excellent written technical documentation skills and ability to generate concise and accurate ... **Position Overview** The Principal Enterprise Architect is the technical ...business continuity and disaster recovery implementation + Expert level technical documentation skills + Certifications are a… more
- Oracle (Raleigh, NC)
- …years of experience in AI/ML solution development, with 5+ years in senior or principal technical roles. + Proven track record leading large-scale, production AI ... discussions, helping shape the future of responsible healthcare AI. + Publish technical insights, speak at conferences, and mentor Principal -level engineers and… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …in Quality Systems and with GT products/processes + Prepares, organizes, and tracks documentation and requests in support of regulatory and customer audits + ... initiatives for process improvement. The incumbent is a professional with high technical competency who leads project or discipline teams. The employee influences… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …and regions. Hours: Monday to Friday - 8:00 am to 5:00 pm ** Principal Quality Associate** The Principal Quality Associate, Quality Assurance Filling Business ... data analysis for stability, etc. The incumbent is a professional with high technical competency who leads project or discipline teams. Can make quality decisions… more
- Prime Therapeutics (Raleigh, NC)
- …and drives every decision we make. **Job Posting Title** Compliance Analyst Principal (Performance and Oversight) - Remote **Job Description** The Compliance ... Principal is responsible for supporting Oversight and Monitoring of...assisting leaders in the implementation, monitoring, and maintenance of regulatory requirements throughout the enterprise. This position acts as… more
- Oracle (Raleigh, NC)
- …surveillance processes are embedded into SDLC activities. + Translate regulatory requirements into clear engineering controls, documentation workflows, ... engineering programs in regulated environments. + Demonstrated ability to translate regulatory requirements into technical workflows, SDLC practices, and… more
- ManpowerGroup (Raleigh, NC)
- Our client, a leader in medical device innovation, is seeking a Principal Mechanical Engineer to join their team. As a Principal Mechanical Engineer, you will be ... skills, which will align successfully within the organization. **Job Title:** Principal Mechanical Engineer **Hybrid role:** Flexible Schedule- Part-Time 3 days in… more
- Oracle (Raleigh, NC)
- …often exceeds- regulatory , customer, and security requirements. The Role - Principal Compliance Program Manager We are seeking a highly motivated individual to ... join our team as a Principal Compliance Program Manager, specializing in data center operations....critical thinking skills. .Proven ability to combine business acumen, technical acumen and process expertise to define client (internal/external)… more
- Oracle (Raleigh, NC)
- …across multiple functions within Oracle, ensures compliance with strict regulatory standards, and provides design leadership from concept through execution. ... ensuring milestone achievement, quality, compliance, and adherence to company and regulatory standards. + Conduct site assessments, participate in design meetings,… more
- Oracle (Raleigh, NC)
- …through data and technology. Career Level - IC4 **Responsibilities** **Responsibilities** 1. ** Technical Leadership** : * Serve as a key technical expert ... Develop and fine-tune LLMs for healthcare-specific use cases, such as automated documentation , question answering, and predictive analytics. * Apply generative AI to… more
- Truist (Raleigh, NC)
- …manner by receiving and investigating incidents or service tickets. 4. Provides technical consultation on extremely challenging or unusual situations. 5. May lead ... innovative solutions. 9. Mentors less experienced teammates to build technical expertise. 10. May have people management responsibilities. **QUALIFICATIONS**… more
- Oracle (Raleigh, NC)
- …and network projects. They bring a wealth of expertise in project management, technical design, and on-site construction, ensuring that our data centers meet the ... stakeholders, manage high-stakes vendor relationships, and navigate the complexities of regulatory compliance. Your ability to anticipate and mitigate risks to… more
- Oracle (Raleigh, NC)
- …of ** regulatory compliance processes** (FDA, ISO, cGMP) and quality documentation management. + Familiarity with **Oracle Visual Builder Studio** , **BI ... modules, ensuring alignment with compliance standards. + Partner with **Integration and Technical teams** to design robust data flows between PLM and ERP systems… more
