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
- ...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
$127k - $190.4k
...Manager, GMP Inspection Readiness The Senior Manager... ..., Biologics, and Medical Devices. Responsibilities include... ..., and supporting regulatory inspections from the... ...role requires strong project management, strategic... ...up action, including coordination of readiness activities...RegulatoryMedical deviceContract workWork experience placementSummer workRemote workFlexible hours2 days per week- ...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
- ...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 critical in ensuring patient safety, regulatory compliance, and effective risk... ..., CAPA, and risk files. Maintain audit‑ready records. Requirements Bachelor’s or Master... ...related field. 515 years of experience in: Medical device risk management & CAPA. HHE / product safety...RegulatoryMedical device
- ...Turnberry offers to clients. As a Project Coordinator and Business Operations... ...challenges including regulatory compliance, full-scale implementation... ...status updates Support readiness of materials for governance... ...healthcare package (medical, dental, vision), disability...RegulatoryHourly payWork experience placementFlexible hours
$170k - $195k
...central role in advancing device strategy, execution, and readiness for commercialization.... ...Management: Manage and coordinate development activities across... ..., Clinical, Commercial, Regulatory, and Manufacturing teams... ..., drug–device, or medical device development Demonstrated...RegulatoryMedical deviceWork at officeWorldwideFlexible hours- ...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 deviceFull timeImmediate start
- ...years' experience. Must have medical device experience, disposables... ...wear multiple "hats". Be ready to participate in quality systems... ...engineering, manufacturing, regulatory activities, etc.... ...starter who handles multiple projects at the same time. Willing...RegulatoryMedical deviceWorldwideFlexible hours
- ...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
- ...— 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
- ...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
- ...Reimbursement Practice The best medical device in the world means nothing... ...sharp, hungry researchers ready to dive into the deep end,... ...healthcare systems. Every project is different because every technology... ...'ll collaborate daily with regulatory strategists, clinical...RegulatoryMedical deviceWork at officeImmediate startWork from homeShift work
$178.5k - $257.83k
...Advertising and Promotion, Global Regulatory Affairs Location:... ...activities for assigned products. Ready to get started? Join the... ...Experience within pharmaceutical or medical device Regulatory Affairs... ...of managing product support projects on topics specific to the functional...RegulatoryMedical device- ...quality assurance function as we scale our medical device operations across the United States and... ...with engineering, operations, and our regulatory lead, and you will be the person the... ...with. Own internal audits and inspection readiness, and serve as the quality counterpart...RegulatoryMedical deviceFull timeWork at officeFlexible hours
$87k - $195k
...more junior team members on projects and empowering the leadership... ..., biotechnology, medical devices, managed care, and health IT... ...analysis of clinical readouts, regulatory developments, earnings calls... ...topics into clear, executive-ready strategic recommendations...RegulatoryMedical deviceWork at officeLocal areaFlexible hours- ...Surgical is an early‑stage medical device startup focused on transforming... ...alignment across Quality, Regulatory, Operations, and R&D. This... ...troubleshooting, and build readiness. Lead resolution of... ...design control documentation. Coordinate with internal teams on issue...RegulatoryMedical deviceFull timeContract work
$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- Planet Pharma Group seeks a Principal Medical Device Engineer located in Cambridge, Massachusetts... ...devices while ensuring compliance with regulatory standards. With a minimum of 15 years'... ...collaborate across teams to guarantee project success. This hands-on position also...RegulatoryMedical device
- ...a System Engineer specializing in hardware in Boston, Massachusetts. This role involves developing new EEG device systems that comply with business and regulatory requirements, while collaborating with multiple engineering teams. The ideal candidate will have a solid background...RegulatoryMedical deviceRemote jobWork at office
- Planet Pharma is seeking a Principal Medical Device Engineer in Cambridge, Massachusetts. This... ...while ensuring compliance with regulatory standards. The ideal candidate should have... ...development. The engineer will manage projects, mentor junior staff, and ensure high-quality...RegulatoryMedical device
$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 homeWorldwideMonday to Friday$43.92 - $68.62 per hour
...Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston... ...completeness, consistency, and audit readiness Supporting verification, validation, and... ...Notified Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EUMDR)...RegulatoryMedical deviceHourly payContract workRemote work$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... ...to ensure compliant, inspection‑ready processes and documentation. Leads departmental...RegulatoryMedical deviceTemporary workWork at officeLocal areaRemote workWorldwide$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$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 officeRemote workFlexible hours- ...to support Lifecycle Management within medical device products. The role requires collaboration... ...with engineering, manufacturing, and regulatory teams to ensure compliance with design... ...-solving, effective communication, and project leadership are essential for success....RegulatoryMedical device
- ...and leading strategic projects focused on... ...leadership, marketing, medical affairs, reimbursement... ...portfolio assets. Coordinate commercial readiness and go‑to‑market (GTM... ...Reimbursement, and Regulatory teams to support product... ...healthcare, medical device, diagnostics, radiopharmaceuticals...RegulatoryMedical devicePrivate practiceNight shift
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