Software Compliance Lead (FDA/21 CFR 11) | Hybrid Cambridge
Motion Recruitment Partners LLC
Motion Recruitment Partners LLC is seeking a Staff level Compliance Manager for a commercial SaaS company in the biotech/medtech space, Cambridge, MA. You will ensure FDA, HIPAA, ISO, SOC compliance and align validation with software products, plus oversee release management and compliance frameworks. Ideal candidates have 21 CFR Part 11 and EU Annex 11 experience, built Quality Management Systems, authored GxP Validation Packages, and led audits for top pharma/biotech firms. #J-18808-Ljbffr Motion Recruitment Partners LLC
$103.6k - $176.4k
...commercializing Enterprise Software projects according to strict... ...you to be onsite working a Hybrid schedule at 125 Summer Street... ...Manager the candidate will: Lead complex software development... ...regulated environments, ensuring compliance with FDA, ISO 13485, IEC 62304,...SuggestedHourly payFull timeTemporary workSummer workMonday to FridayFlexible hours$157k - $249k
Job TitleR&D Technical Lead — Advanced Software Development, ICE Imaging (Cambridge)Job DescriptionR&D Technical Lead — Advanced Software Development, ICE Imaging (Cambridge)The R&D Technical Lead will provide technical leadership for the Advanced Development (AD) Software...SuggestedFull timeWork at officeImmediate startWork visaRelocation package3 days per week- Accenture Products & Platforms is seeking a seasoned Software Presales Lead for North America. We are looking for a product expert to support... ...aligns with broader client business goals, such as automation, compliance, and digital transformation.Broad knowledge of the...SuggestedFull timeWork experience placementLive inWork at officeLocal area
$137k - $236k
...assigned. This position will support software enabled medical devices with... .../development partners and lead/enable strong cross-functional... ..., and other functions. This Hybrid role may require travel up to... ...in Regulatory Affairs within FDA regulated medical device/software...SuggestedWork visa- ...responsible for shaping and scaling modern software delivery models across sponsor portfolios... ...work experience.Demonstrated experience leading software or digital transformation... ...DoD Secret clearanceWillingness to support hybrid on-site engagement as required by sponsors...SuggestedWork experience placementInternshipLocal area
$173k - $216.3k
...experienced Principal Product Manager, Software to join our team, focusing on... ..., Security, and Regulatory Compliance. In this senior individual-... ...position is considered hybrid, allowing for a combination of... ...just writing requirements.Lead without authority. Influence...Full timeTemporary workWork at officeImmediate startRemote workWork from homeWork visa3 days per week- Harvard University is seeking a qualified individual for a position in bioinformatics software development to manage complex databases and collaborate on research projects. The successful candidate should possess extensive experience in scientific database production and...Flexible hours
- Axoft is seeking a Design, Process, and Software Quality Risk Specialist to own organizational risk management across product design, development processes, and software. The role prioritizes software risk but supports risk management across the organization as the device...
- Scientific Systems Company, Inc. is seeking a Lead Autonomy Software Engineer in Burlington, Massachusetts. This role involves leading a small... ...and Python. The position offers a comprehensive benefits package and a hybrid work schedule. #J-18808-Ljbffr Scientific Systems
$103.6k - $176.4k
...Validation (V&V) strategy for Software as a Medical Device (SaMD) and... ...platforms. Drives regulatory compliance, quality metrics, traceability... ...quality, ensuring alignment with FDA expectations and Haemonetics... ...standards.Key Responsibilities: Lead and define software V&V...Hourly payFull timeTemporary workMonday to FridayFlexible hours$133.1k - $306.4k
...This is a unique opportunity to lead a key part of OCI's... ...that seamlessly supports OCI, hybrid, and multi-cloud environments.... ...exceptionally talented team of software engineers in advancing this critical... ...not eligible for vacation. #11 paid holidays # Paid sick leave...Temporary workFlexible hours$150k - $205k
Formlabs in Somerville, Massachusetts is seeking a Software Product Manager to lead the product management team, oversee the full product life cycle, and connect product development with engineering teams. With over 5 years of experience in product management, you will...$150k - $190k
...Location: Onsite in North Reading, MA Responsibilities Lead system-level verification and validation of robotics software systems, including autonomy, perception, motion... ...status, age, genetic information, or pregnancy. Compliance Notice: Alten USA is a federal contractor...For contractors$134k - $265k
...Summary Domain Tech Lead — Infrastructure Patching... ...verticalized sector solutions in software, data, AI, network, and hybrid cloud infrastructure.... ...for this role ends on 8/21/26.Work you'll doAs a Domain... ...cycles while ensuring compliance, stability, and security across...Local area$226.8k - $306.8k
A leading biotech firm in Cambridge, MA, seeks a Senior Director to lead lab-to-product operational technology. This role involves managing core digital... ...research and manufacturing processes, and ensures compliance with GxP standards. Candidates should have 15+ years of...- ...MIT’s IP portfolio, evaluate technologies, market opportunities, and coordinate with faculty and industry to license rights. This hybrid role requires a Bachelor's degree and at least five years in university tech transfer licensing; strong negotiation, communications...Work at office
$160k - $190k
Lead DevOps Engineer (Infrastructure Scale & Enablement)Stack: AWS (ECS, Cloud-First), Terraform, GitHub, MongoDB, Snowflake, GCPIf you... ...in face-to-face interactions, and foster a sense of community.Hybrid: For those who prefer a balance between office and remote work,...Work at officeRemote workFlexible hours$121k
...of perspectives to spark change. BCG delivers solutions through leading-edge management consulting along with technology and design,... ...field, or equivalent practical experience.Minimum 5+ years of software development experience delivering production-grade applications...Work at officeLocal area- ...seeking a cybersecurity leader to advance software supply chain security and DevSecOps... ...collaboration with Engineering teams. You will lead a team, partner with developers, and... ...and documentation to measure progress and compliance. Strong experience in Java, .NET, Python...
- The Phia Group is seeking a Quality Manager - Software Projects to lead QA strategy across our software platforms. You will define quality standards, drive test planning, and oversee automated testing initiatives in a fast-paced, healthcare-focused environment. With 5+...
$101.6k - $152.4k
...Commercialization Manager, Sustainability Software and play a pivotal role in... ...in the region. This role is Hybrid, open to our US Hubs. As the... ...operational cadences, and lead strategic transformations to... ...standards of ethics and compliance, and we believe that trust is...Full timeTemporary workLocal areaFlexible hours$184.9k - $250.2k
We are looking for a Software Development Manager to play a leadership role on this growing... ...Come join our team in Boston's Seaport and lead the team in managing Windows filesystems... ...Artificial Intelligence (AI), security, hybrid and enterprise applications. We maintain...Flexible hours- Anduril Industries is seeking a technical leader to own software for a maritime product. You will set objectives, build cross-functional teams, and drive projects to completion while mentoring a small team. You will oversee the design, implementation, and evolution of...
$220k - $292k
...contracts while simultaneously performing Robot-as-a-Service (RaaS) AUV operations. WHAT YOU'LL DO Act as a technical leader owning software for one of our maritime products. Draw on both your technical expertise and leadership skills to set objectives, build cross-...Full timeWork experience placementFlexible hours$135k - $160k
Werfen, based in Bedford, Massachusetts, is seeking a Project Manager for product development. This role involves leading project teams, managing budgets, and ensuring successful product development. Candidates should have a strong background in project management with...- ...Architecture & Engineering with hands-on experience in AppSec, software supply chain security, CI/CD pipelines, and SSDLC. The role involves... ..., while automating security processes at scale. You will lead the Software Supply Chain Security team, partner with engineering...
- The Software and Electronics Engineering Group (76) collaborates with every research area at the Laboratory to create systems that accomplish... ...and Electronics Engineering, is seeking a Software Analysis Lead to work on the full software lifecycle for complex prototypes that...
$124k - $164k
...opportunity We currently have an opportunity for a Technical Lead – API and Integration Development to join our Corporate IT team... ...Canton, MA; Boston, MA; Farmington, CT or Raleigh, NC offices on a hybrid schedule. We are seeking a technically strong and hands-on...Full timeWork at officeFlexible hours$102.48k - $163.97k
Job Title Software Design Quality Engineer Job Description The Software Design... ...their accuracy and regulatory compliance throughout the software lifecycle. Your role: Leads the assessment of software... ...minimum of 5+ years’ experience in FDA regulated, IEC 62304 medical device...Full timeWork at officeImmediate startWork visaRelocation package3 days per week$131.25k - $210k
...with our ecosystem of devices and cloud software. Like our products, we work better together... ...Product Manager at Axon, you will lead the definition and delivery of innovative... ...out of our Boston, MA Office and follows a hybrid schedule. We rely on in-person collaboration...Temporary workWork experience placementWork at officeRemote workShift work
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