Medical Device Project Coordinator - Regulatory Readiness
IntePros
A global medical device company is seeking a Senior Project Coordinator in the Boston area to support system separation initiatives while coordinating with director-level leadership in Quality, R&D, and Regulatory Affairs. The ideal candidate will have strong organizational abilities, thrive in complex environments, and assist in managing interdependencies across multiple workstreams. Responsibilities include preparing meeting materials, monitoring project updates, and ensuring timely communication between teams. The role requires experience within regulated environments and excellent coordination skills. #J-18808-Ljbffr IntePros
Vacancy posted 8 hours ago
Similar jobs that could be interesting for youBased on the Medical Device Project Coordinator - Regulatory Readiness in Boston, MA vacancy
- Intepros' valued global medical device client is seeking a Senior Project Coordinator to support critical system separation... ...leadership across Quality, R&D, and Regulatory Affairs, ensuring alignment,... ...dependencies, tracking readiness activities, and supporting the...RegulatoryMedical deviceLocal areaShift work
- ...ensuring compliance with regulatory requirements, quality... ...History Files (DHF), Device Master Records (DMR),... ...development and manufacturing readiness. Facilitate Design and... ...an FDA-regulated medical device environment.... ...manufacturing transfer projects. Knowledge of Design...RegulatoryMedical device
- ...developed in compliance with regulatory standards, quality... ...and successful project milestones. Validates... ...manufacturing, ensuring process readiness. Guide comprehensive... ...Bachelor's degree in medical sciences, Healthcare... ...Knowledge of medical device regulations, requirements...RegulatoryMedical device
$101.64k - $133.41k
...role of Engineer III for device development / human... ...Marketing, Quality, and Regulatory, clinical development through... ...and development of medical device and combination... ...writing internal reports, project summaries, and internal... ...leaders and peers ready to lift you in marketing...RegulatoryMedical deviceHourly payTemporary workWork at officeAlexion Pharmaceuticals
Boston, MA3 days ago$90 - $130 per hour
...Job Description Job Title: Project Manager (Medical Devices III) Position Type: Contract... ...verification and validation, manufacturing readiness, and regulatory submission activities. The... ...review. Regulatory & Quality Coordination: Partner with Regulatory Affairs...RegulatoryMedical deviceContract workWork experience placementIntelliPro Group Inc.
Cambridge, MAa month ago- ...development consultancy specializing in medical devices, robotic systems, and automation is... ...support both internal quality processes and regulatory submissions, ensuring your solutions are robust, maintainable, and production ready.Required Skills & ExperienceStrong...RegulatoryMedical deviceFull time
$120k - $160k
...products meet WHOOP quality standards, regulatory requirements, and member expectations from... ...planning, risk management, validation readiness, root cause analysis, and continuous... ...wearable technology, wellness/fitness, medical device, or high-tech industriesExperience supporting...RegulatoryMedical deviceFull timeWork at officeRelocation$170k - $230k
...the function, and partner deeply across regulatory, quality, clinical science, product,... ...required to operate inside a regulated medical device development environment (FDA, IEC 62304... ...change control, design history, and audit readiness in fast-moving ML programsDemonstrated...RegulatoryMedical deviceFull timeWork at officeRelocation$214k - $249.8k
...products, peptide-based products, medical devices, combination products, and... ...Operations, Quality, Regulatory CMC, and external partners to... ...submissions, clinical bulk supply readiness, commercial preparedness,... ..., and alignment with project priorities. - Build external...RegulatoryMedical device$130k - $170k
...a rapidly growing, Boston-based medical technology company using AI to help... ...regulated Software as a Medical Device (SaMD) environment. You'll work... ..., AWS hardening and audit readiness. You will translate complex security and regulatory requirements into practical controls...RegulatoryMedical deviceWork at office- ...laboratory in accordance with the regulatory standards and the quality... ...in maintaining audit readiness. This position formally serves... ...and conducted. • Lead and coordinate timely resolution of any... ...interfacing with regulatory bodies. Medical device and/or invitro diagnostics...RegulatoryMedical deviceImmediate start
Nanobiosym
Cambridge, MA7 days ago - ...required for Cognito’s continued growth, IPO readiness, and long-term platform leadership. This... ...commercial legal infrastructure. Regulatory & Compliance Provide executive-level legal leadership within a regulated medical device environment, partnering with Regulatory,...RegulatoryMedical deviceContract work
Cognito Therapeutics, Inc.
Cambridge, MA4 days ago $210k - $230k
...with a particular focus on Software as a Medical Device (SaMD). You will own operational... ...concept and feasibility through validation, regulatory submission, launch, and post-market evidence... ..., and Trial Master File inspection readiness.Ensure studies are conducted in...RegulatoryMedical deviceFull timeWork at officeRemote workRelocation$238k - $374k
...worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product,... ...and robust regulatory strategies for medical devices and drug-device combination... ...vendors to ensure compliant, inspection-ready processes and documentation.Leads...RegulatoryMedical deviceMinimum wageTemporary workWork at officeLocal areaRemote workWorldwide$117k - $201.25k
...possibilities of Orthopaedics? Ready to join a team that’s... ...part in supporting regulatory submissions and... ...plans for complex medical devices, including system verification... ..., reproducibility.· Coordinate and manage engagement... ...R&D teams.· Support project resource and schedule...RegulatoryMedical deviceFull timeLocal areaImmediate start$133.8k - $200.6k
...assembly manufacturing operations supporting medical device and combination products. The role is... ...change controls, supplier quality, and regulatory compliance while partnering with... ...technology transfers, and manufacturing readiness.Experience working with Contract Manufacturing...RegulatoryMedical deviceFull timeContract workSummer workRemote workFlexible hours2 days per week- ...design concepts into production-ready circuit solutions.Design and... ....Actively contribute to regulatory and quality processes, with particular... ...CLA certificationMedical device launch experiencePhD or MS/ME... ...to-end experience bringing a medical device or similarly regulated...RegulatoryMedical device
Nanobiosym
Cambridge, MA24 days ago $122.25k - $176.58k
Job title: GRA Device Associate - Medical Devices and Combination Products (Senior... ...NJAbout the JobThe Global Regulatory Affairs (GRA) Device team... ...health authorities worldwide. Ready to get started?The GRA... ...objectives into actionable project strategies.Language:Strong...RegulatoryMedical deviceFull timeLocal areaWorldwide$150k - $210k
...features, requiring a strong balance of ML rigor, production readiness, and regulatory awareness. Join us in pushing the boundaries of wearable... ...-risk ML systems (e.g., digital health, software as a medical devices), including familiarity with validation, documentation, and...RegulatoryMedical deviceFull timeWork experience placementWork at officeRelocationWhoop
Boston, MA18 hours ago- ...PCB design and enhancement projects, ensuring scalability, manufacturability... ...into robust, production-ready circuit designs.Review... ...functional testing.Support regulatory and quality processes with a... ...experience developing and launching medical devices or similarly regulated...RegulatoryMedical device
Nanobiosym
Cambridge, MA4 days ago $92k - $148.35k
...possibilities of Orthopaedics? Ready to join a team that’s... ...critical part in supporting regulatory submissions and product releases... ...system test plans for complex medical devices, including system... ...solving across R&D teams.Support project resource and schedule planning...RegulatoryMedical deviceFull timeWork at officeLocal areaImmediate start3 days per week$181k - $288k
Job TitleDirector, Quality & Regulatory- Mergers & Acquisitions (M&A)Job DescriptionThe Director... ...lifecycle management.Drive Day 1 readiness and Day 2 execution, partnering with... ...years’ experience in FDA regulated global medical device environments (Class III products/...RegulatoryMedical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week$120k - $180k
...developing innovative medical technologies that... ...Principal Regulatory Affairs Specialist... ...modified medical device products to the market... ...into project/product requirements... ...compliance.Oversee and coordinate multiple... ...audit and inspection readiness activities.Recommend...RegulatoryMedical deviceFull timeH1bWork at officeLocal areaImmediate startWorldwideFlexible hours$22.22 - $31.71 per hour
...performing teams drive groundbreaking medical discoveries and invite all... .... CHOIR is seeking a Project Coordinator for an NIH/NCCIH-funded UG3/UH... ...focused on protocol finalization, regulatory approvals, staff training, and site readiness, followed by a UH3 efficacy phase...RegulatoryHourly payWork at officeRemote workShift work$220k - $245k
...generation.Lead the development of enterprise-ready value dossiers and structured evidence... ...-functionally with Clinical Science, Regulatory Affairs, Data Science, Product, Legal,... ...economics within digital health, medical devices, diagnostics, or healthcare technology....RegulatoryMedical deviceFull timeWork at officeRemote workRelocation- ...Our platform enables audit readiness in weeks through multi-standard... ...of pharma, biotech and medical device companies The Director of... ...make sure every motion is coordinated and every budget dollar is... ...life sciences, compliance, or regulatory tech is a meaningful...RegulatoryMedical deviceTemporary workRemote workWorldwideHome officeFlexible hoursShift work
Qualio
Boston, MA13 days ago $103.6k - $176.4k
...into compelling commercial content, field-ready tools, and go-to-marketexecution across... ...on product improvements while ensuring regulatory compliance.Own conference content... ...or downstream marketing experience in medical device RequiredOther Demonstrated track record...RegulatoryMedical deviceHourly payFull timeTemporary workRemote workMonday to FridayFlexible hours- Bring more to life. Are you ready to accelerate your potential and make a real difference... ..., Finance, Legal, Manufacturing, Regulatory, Quality, and other teams to launch and... ...regulated biotechnology, pharmaceutical, or medical device-related field is requiredDemonstrated...RegulatoryMedical deviceFull timeRemote workWork from homeFlexible hours
$103.6k - $176.4k
...Enterprise Software projects according to strict deadlines... ...resources and coordinating the efforts of team members... ...programs for medical device products in regulated... ...Engineering, Quality, Regulatory Affairs, Cybersecurity... ...documentation, and release readiness activities for...RegulatoryMedical deviceHourly payFull timeTemporary workSummer workMonday to FridayFlexible hours- ...Associate Director, AS&T Projects & Strategy, you... ...and oversee the coordination of all analytical... ...such as Regulatory Affairs, CMC, and... ...Inspection (PLI) readiness, BLA preparation,... ...to: ~ Medical, Dental and Vision... ...biologics, and medical devices. In the coming...RegulatoryMedical deviceHourly pay
Biontech
Cambridge, MAa month ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Medical Device Project Coordinator - Regulatory Readiness. Be the first to apply!
Related searches
- medical coordinator Boston, MA
- clinical pharmacy coordinator Boston, MA
- medical scheduling coordinator Boston, MA
- clinical data coordinator remote Boston, MA
- clinical data coordinator Boston, MA
- medical equipment coordinator Boston, MA
- clinical trial coordinator Boston, MA
- localization project coordinator Boston, MA
- project administrator Boston, MA
- translation project coordinator Boston, MA