- Olympus Corporation of the Americas (Westborough, MA)
- …support across the global organization and assists development teams in applying regulatory rigor to Agile SW development practices. This position provides subject ... matter expertise, technical guidance, and leadership for the application of health...for the application of health and medical device SW regulatory standards to the Olympus SDLC, including IEC 62304,… 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 (Boston, MA)
- …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 (Boston, MA)
- **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 (Boston, MA)
- …within regulated environments or healthcare technology. Demonstrated ability to translate regulatory and compliance requirements into technical processes and ... collaborating across engineering, risk, and compliance functions. Excellent communication, documentation , and executive presentation skills. Familiarity with regulatory… more
- J&J Family of Companies (Danvers, MA)
- …Learn more at https://www.jnj.com/medtech We are searching for the best talent for ** Principal Regulatory Compliance - Lead Auditor** to be in Danvers, ... Massachusetts The position of the Principal Regulatory Compliance is responsible for establishing...with Sector functions and across Operating Units + Balanced technical understanding of products and processes combined with outstanding… more
- Oracle (Boston, MA)
- …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
- 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
- Eversource Energy (Westwood, MA)
- … \(e\.g\., H\-1B, OPT, STEM OPT, CPT, TN, J\-1, O\-1, etc\.\)\. Principal Engineer in Transmission System Planning provides technical leadership, conducts ... unique and/or complex engineering problems, and is accountable for major technical recommendations\. Principal Engineer in Transmission System Planning provides… more
- Oracle (Boston, MA)
- …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
- Hologic (Marlborough, MA)
- …projects concurrently. + Excellent verbal, written, and presentation communication skills, including technical documentation and the ability to adapt for ... Principal Systems Engineer/Architect Newark, DE, United States Marlborough,...regulatory and quality standards. + Serve as a technical expert and mentor, guiding and supporting engineers across… more
- Medtronic (Boston, MA)
- … documentation , review participation, and active knowledge sharing. + ** Regulatory & Standards Compliance** - Ensure alignment with applicable standards (eg, ... connected, compassionate world. **A Day in the Life** The Principal Product Security Engineer plays a critical role in...NIST, IEC 60601-4-5, IEC 81001-5-1) and support security documentation efforts for global regulatory submissions. +… more
- Eversource Energy (Westwood, MA)
- …immigration documents, or any work authorization that requires company involvement or documentation \(e\.g\., H\-1B, OPT, STEM OPT, CPT, TN, J\-1, O\-1, etc\.\)\. ... training, or other business needs\) or should the policy change\._ The Principal Engineer performs an Engineering Department leadership role\. Recognized as having … more
- Eversource Energy (Westwood, MA)
- …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
- Sanofi Group (Cambridge, MA)
- **Job Title:** Principal Capability Professional for Registration Tracking xEVMPD **Location** : Morristown, NJ/ Cambridge, MA **About the Job:** Join the engine of ... capability roadmaps with enterprise impact, serve as a strategic bridge between regulatory SMEs, business process owners, and digital product teams, and lead the… 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
- Prime Therapeutics (Boston, MA)
- …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
- 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
- Oracle (Burlington, MA)
- …hardware specifications, bills of materials, configuration guides, and all necessary technical documentation . + Develop, implement, and automate test plans ... interface guides, and compliance reports + Navigating global safety and EMC regulatory requirements for product certification + Excellent technical leadership,… more
