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
- 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
$110 - $140 per hour
...Overview The Inspection Readiness Lead will be... ...management, and stakeholder coordination. Key... ...compliance gaps Lead project management and reporting... ..., pharmaceutical, or medical device industry ~ Direct,... ...Familiarity with FDA regulatory expectations (inspection...RegulatoryMedical deviceContract workTemporary workRemote workFlexible hours$127k - $190.4k
...Manager, GMP Inspection Readiness plays a key role in... ..., Biologics, and Medical Devices. Responsibilities include... ..., and supporting regulatory inspections from the... ...role requires strong project management, strategic... ...action , including coordination of readiness activities...RegulatoryMedical deviceContract workWork experience placementSummer workRemote workFlexible hours2 days per week- ...ensure compliance with FDA regulations. The successful candidate will have over 5 years’ experience in quality operations within medical device manufacturing and will be responsible for risk assessments, QMS documentation, and cross-functional team leadership. Full-time...RegulatoryMedical deviceFull time
- ...Manufacturing Operations Engineer to support production readiness and optimize processes for medical technology products. In this hands-on role, you will... ...3-7+ years in manufacturing engineering, focusing on regulatory environments. The position offers unlimited paid time...RegulatoryMedical device
- ...Health Technology (DHT) and Software as a Medical Device (SaMD) initiatives within a highly... ...environment. This role will provide quality and regulatory oversight for AI-enabled medical... ...throughout the lifecycle Support audit readiness, inspection preparation, and regulatory...RegulatoryMedical device
- ...is critical in ensuring patient safety, regulatory compliance, and effective risk... ...CAPA, and risk files. Maintain audit-ready records. Requirements: Bachelor... ...5-15 years of experience in: Medical device risk management & CAPA. HHE / product...RegulatoryMedical device
- ...leading organization in the medical device manufacturing space is... ...Verification & Validation (V&V) Coordinate internal and customer-... ...ramp-up Ensure readiness across manufacturing, quality... ...quality systems, and FDA/ISO regulatory environments Preferred...RegulatoryMedical device
- ...candidates. Industry: Medical Devices - Class III Long-Term Implantable... ...seeking an experienced Project Manager (Consultant) to... ...validation, manufacturing readiness, and regulatory submission activities. The... ...control deliverables. - Coordinate validation activities including...RegulatoryMedical deviceContract workLocal areaRemote work
- Job Title: Project Manager Location: Cambridge, Massachusetts... ...to lead complex medical device development and regulatory submission activities within... ...and timelines. Coordinate with Regulatory Affairs... ...completeness, traceability, and readiness for regulatory review,...RegulatoryMedical deviceContract work
- ...Consultant with deep expertise in Software as a Medical Device (SaMD) and hands-on experience guiding... ...workflows, and can advise our team on regulatory, compliance, safety, and validation... ...Conduct gap assessments for regulatory readiness and documentation completeness...RegulatoryMedical deviceContract workPart timeRemote work
- ...is out there. Better medications, better outcomes, better... ...the Senior Manager, Regulatory Affairs Advertising and... ...advertising campaigns. Ready to get started?... ...defense, and development projects. Serve as the primary... ...pharmaceutical or medical device advertising and promotional...RegulatoryMedical deviceWork experience placement
$85.6k - $149.4k
...the Role: As the Senior Regulatory Affairs Specialist, you will... ...expansion of our Software as a Medical Device (SaMD) portfolio across... ...Documentation Ensure audit-readiness of DHFs, cybersecurity files... ...~ Strong communication and project leadership skills The above...RegulatoryMedical deviceWork at office$124.61 - $138.45 per hour
...Benefits: Weekly pay, medical, dental, and vision... ...an experienced Project Manager Consultant to... ...implantable medical device within the Implantable... ...validation, manufacturing readiness, and regulatory submission efforts.... ...& Quality Coordination Partner with Regulatory...RegulatoryMedical deviceWeekly payPermanent employmentContract workRemote work- ...developing innovative wearable devices that improve human health and... ...flows Support manufacturing readiness (DFM, testing procedures,... ...Experience with wearables, medical, or sleep tech devices Knowledge... ...Manufacturing, certification, or regulatory exposure (FCC, CE) What We...RegulatoryMedical deviceFull timeContract work
$130k - $150k
...management system implementations and regulatory compliance strategies for cutting-edge medical device clients as we scale our AI-... ...regulatory landscapes and is ready to scale your impact through... ...independently on complex quality assurance projects requiring minimal oversight....RegulatoryMedical deviceFull timeWork at officeWork from homeMonday to Friday$120k - $140k
...StemWave is a fast-growing medical device company based in Massachusetts... ...to support production readiness, process optimization, and operational... ...Quality Engineering and regulatory expectations (ISO 13485, FDA... ...company growth, take on new projects, and further your career At...RegulatoryMedical deviceFull timeWork at office- ...— Labeling Systems (Medical Device / Pharma) Duration... ...requirements and backlog work, coordinate cross-functional... ...system migration projects and coordinate day-to... ..., Technical Quality, Regulatory Affairs (as needed),... ...activities and audit-ready documentation. Lead...RegulatoryMedical deviceContract workFor contractorsRemote work
- ...Support the execution of robotics projects at multiple US sites... ...operational value and compliance readiness where necessary. Lead and... ...ability to adapt to diverse regulatory requirements and operational... ...industries (Pharma/biotech/medical devices) with familiarity with GMP,...RegulatoryMedical deviceWorldwide
- ...Job Description Title: Project Manager III (PO&T) Location... ...7–12+ years Industry: Medical Devices – Class III Long-Term... ...validation, manufacturing readiness, and regulatory submission activities. The... ...Regulatory & Quality Coordination Partner with Regulatory...RegulatoryMedical devicePermanent employmentContract workRemote work
- ...Key Responsibilities Regulatory Affairs (U.S. Focus)... ...lead for clinical and medical device products, overseeing... ...Maintain inspection readiness and ensure data integrity... ...Collaboration Lead coordination between Clinical... ...EU MDR/IVDR. Strong project leadership and stakeholder...RegulatoryMedical deviceRemote work
- ...pharmaceutical, biotechnology, and medical device safety and efficacy... ...Specific responsibility in the project phase of construction of the... ..., start-up and operational readiness of all GMP Utilities. During... ...excellence, in compliance with regulatory and company requirements....RegulatoryMedical device
- ...-stage design concepts into production-ready circuit solutions. Design and integrate... ...verification. Actively contribute to regulatory and quality processes, with particular... ...yrs) Java NI CLD or CLA certification Medical device launch experience PhD or MS/ME in EECS...RegulatoryMedical device
- ...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 audit... ...with regulatory bodies. Medical device and/or invitro diagnostics...RegulatoryMedical deviceImmediate start
$123.6k - $154.5k
...development programs for regulated medical devices and IVDs. Partnering closely with Regulatory Affairs, Quality Systems,... ...based, effective, and inspection-ready approach to CDx product development... ...Quality and functional leaders to project CDx Quality Assurance Product...RegulatoryMedical deviceFlexible hours- ...PCB design and enhancement projects, ensuring scalability, manufacturability... ...into robust, production‑ready circuit designs. Review... ...testing. Support regulatory and quality processes with a... ...experience developing and launching medical devices or similarly regulated...RegulatoryMedical device
$170k - $230k
...including women's health, software as a medical device, wellness monitoring, longevity... ...collaborating with crossfunctional teams that own regulatory, quality, and clinical strategy, to... ...and the ability to deliver production-ready ML services within a quality-managed framework...RegulatoryMedical deviceFull timeWork at officeRelocation$153.2k - $191.5k
...quality for FMI’s regulated medical devices and IVD development processes... ...with Product Development, Regulatory Affairs, Quality Systems, Complaints... ...quality, and inspection ready. This role is critical in... ...Quality and functional leaders to project Design Assurance demand and...RegulatoryMedical deviceFlexible hours- ...-World Data environments, translating regulatory and quality requirements into clear, practical... ...continuous improvement and audit readiness, strengthening vendor oversight, risk-... ...within a regulated industry (e.g., medical devices, pharmaceuticals, life sciences). Proven...RegulatoryMedical device
$92k - $138k
...Sr. Regulatory Affairs Specialist At Medtronic, you... ...for Class II robotic medical devices. This role will... ...product development projects by providing international... ...audit and inspection readiness, and global quality system... ...Directs or performs coordination and preparation of...RegulatoryMedical deviceH1bWork at officeLocal areaWorldwideFlexible hours
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