- Parexel (Concord, NH)
- …to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator ... model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports,… more
- Teleflex (Chelmsford, MA)
- …production documentation to ensure compliance with internal procedures and regulatory standards. - Lead the execution of validation activities (IQ/OQ/PQ), test ... assess quality impact of process or equipment changes and contribute to technical justifications and change control documentation . - Communicate quality risks,… more
- Oracle (Concord, NH)
- …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
- Oracle (Concord, NH)
- **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
- Fujifilm (Concord, NH)
- …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 (Concord, NH)
- …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
- J&J Family of Companies (Danvers, MA)
- …relevant standards. Prepare documentation and reports for audits and regulatory submissions. + Risk Management: Identify technical and operational risks ... Maintain comprehensive records of project activities, progress reports, and regulatory documentation , ensuring transparency and traceability. **Job… more
- Eversource Energy (Manchester, NH)
- …and regulatory expectations\. ** Regulatory & Compliance Support:** Provide technical documentation , justifications to support regulatory filings and ... immigration documents, or any work authorization that requires company involvement or documentation \(e\.g\., H\-1B, OPT, STEM OPT, CPT, TN, J\-1, O\-1, etc\.\)\.… more
- J&J Family of Companies (Danvers, MA)
- …at https://www.jnj.com/medtech **We are searching for the best talent for Principal Production Engineer in Danvers, MA.** **Purpose:** This role provides strategic ... and hands-on technical leadership across manufacturing operations for complex electro-mechanical medical devices used in life-saving cardiac support therapies. This… more
- J&J Family of Companies (Danvers, MA)
- …activities and close the loop on improvement opportunities. + Produce clear, rigorous technical documentation including technical reports, technical ... We are searching for the best talent for a Principal Product Development Engineer. Fueled by innovation at the...risk analyses for internal and external audiences. + Present technical findings, project status, and risk trade-offs to R&D… more
- Evolv Technology (Waltham, MA)
- The Elevator Pitch As Evolv's Principal Electrical Engineer, you'll define the technical direction for our most complex products. You'll be the organization's ... You'll lead by example, mentoring a team of talented engineers, raising the technical bar, and ensuring every design meets the highest standards of performance,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …that enhance R&D GMP Quality processes and operational efficiency. + Contribute technical quality content to regulatory filings and collaborate with CMC ... cGMP development activities. + Proven ability to critically review manufacturing documentation for compliance with procedures, regulations, and regulatory … more
- Oracle (Concord, NH)
- …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
- J&J Family of Companies (Danvers, MA)
- …United States of America **Job Description:** Johnson & Johnson is hiring for a ** Principal Firmware Engineer, Motor Control - Abiomed** to join our team located in ... Lead design, development, and maintenance of embedded software systems. + Provide technical guidance and project leadership to engineering teams. + Collaborate with… more
- Oracle (Concord, NH)
- …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 (Concord, NH)
- …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
- Oracle (Concord, NH)
- …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 (Concord, NH)
- …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
- Wolters Kluwer (Waltham, MA)
- …+ Hands-on experience with design control, risk management, and technical documentation (DHF, traceability matrix, protocols, reports, risk ... The ** Principal SaMD Technical Program Manager** plays...for tracking and communicating key metrics-such as risk information, documentation completeness, and team velocity-to both technical … more
- Oracle (Concord, NH)
- …and continual improvement. _Stakeholder Training & Enablement_ + Design and deliver technical training, guidelines, and documentation for: + Third-party security ... CCPA) and industry standards for wireless monitoring. + Ability to balance technical , business, and regulatory considerations. + Experience with Agile… more
