Regulatory-Ready Project Coordinator (Medical Devices)
jobr.pro
jobr.pro in Sunnyvale, California is looking for a Project Coordinator to support complex product development programs within Advanced Engineering. The role involves ensuring timely execution of deliverables across various subsystems and facilitating governance. The ideal candidate has a Bachelor’s degree and at least 3 years of project coordination experience, with strong communication skills and familiarity with Agile methodologies. The position offers growth opportunities in a dynamic environment. #J-18808-Ljbffr jobr.pro
- ...Function of Position: The Project Coordinator will support complex,... ...Clinical, with a focus on regulatory and clinical readiness. The coordinator will drive... ...including supporting device shipments to clinical sites... ...documentation in accordance to medical device design control...RegulatoryMedical deviceLocal area
- ...professional to provide compliance support to the Regulatory Affairs organization. The ideal... ...Quality Systems, hands-on exposure to medical device regulations, and a strong ability to... ...role is critical for maintaining regulatory readiness. #J-18808-Ljbffr The Fountain GroupRegulatoryMedical device
- ...provide compliance support to the Regulatory Affairs organization by:... .... Participating in RA projects. Qualifications: Degree with... ...experience. Hands‑on exposure to medical device regulations (US FDA, CE),... ...implement mitigations and sustain regulatory readiness. #J-18808-Ljbffr...RegulatoryMedical device
- ...liaison between customers, quality teams, regulatory functions, and cross-functional... ...approach to support compliance and audit readiness objectives. Responsibilities include: Process... ...activities. Working knowledge of U.S. medical device regulations, including 21 CFR Part 820...RegulatoryMedical device
- ...experienced Senior Quality Engineer with expertise in Medical Device Quality Engineering and Regulatory Compliance. The ideal candidate will have hands-on... ...and ISO 13485 requirements. Support manufacturing readiness and quality initiatives throughout product...RegulatoryMedical device
- ...support clinical trial reporting, regulatory submissions, and publications... ...cleaning, interim analyses, medical review, and final study... ...documentation to support audit readiness and collaborative programming... ...pharmaceutical, biotechnology, or medical device industry. Candidate is a...RegulatoryMedical deviceInterim role
$25 per hour
...This role supports quality and regulatory compliance activities within a medical device manufacturing environment. The Compliance... ..., training records, and audit readiness Assist with internal and... ...reporting and metrics tracking Coordinate training activities and monitor...RegulatoryMedical deviceContract workFor contractorsWork at officeLocal area$146.3k - $244.1k
...live more active, healthier lives. Be ready to make something great when you come here... ...Lead Auditor to support regulated medical device features. If you are passionate about the... ...supplier audit program to ensure ongoing regulatory compliance and encourage continuous...RegulatoryMedical deviceRelocation$117k - $159k
...moving them through critical clinical and regulatory milestones so they reach the physicians... ...management activities across multiple medical device clinical studies. This is a hands-on... ...ensure accurate, high-quality, audit-ready clinical data. The ideal candidate has...RegulatoryMedical devicePermanent employmentFull timeWork at officeRelocationVisa sponsorshipWork visa- ...a life. If you're ready to contribute to something... ..., NPI or Sustaining projects to manage. Expected... ..., and identify and coordinate issue resolution and... ...the Pharmaceutical or Medical Device industry (or similar... ...knowledge of ISO and regulatory restrictions. Additional...RegulatoryMedical deviceLocal areaWorldwideFlexible hours
- ...change a life. If you're ready to contribute to something bigger... ...updated on changes in the medical device industry affecting customer... ..., Product Marketing, Legal, Regulatory Affairs, Service Department,... ...or agreement templates. Coordinate drafting of or implement new...RegulatoryMedical deviceContract workWork at officeLocal areaWorldwideFlexible hours
- ...build scalable, future-ready digital platforms that drive... ...and risk management in medical device development, and solid... ...schedule, cost, quality, and regulatory requirements. Act as... .... Mentor and coach project managers and program coordinators on program management best...RegulatoryMedical deviceContract work
- ...more human. If you’re ready to contribute to... ...clinical trials to support regulatory approvals and key evidence... ..., recruitment projections, and creation of study... ...functional alignment with Medical Officers, Medical Affairs... ...pre-market medical device trials; strong knowledge...RegulatoryMedical deviceRemote workWorldwideShift work
$130 - $140 per hour
Director of Regulatory Affairs, Business Excellence 1... ...through process design, project oversight, and... ...execution of action items in coordination with the RegLT.... ...with audit/inspection readiness and regulatory documentation... ...Industry, Medical Device Industry, Regulatory...RegulatoryMedical deviceContract workRemote work- ...life. If you're ready to contribute to... ...product managers, regulatory affairs, and other... ...product-development project teams, the Senior... ...principles to evaluate device‑tissue interaction... ...submissions. Coordinate human factors... ...Experience in medical device or similar...RegulatoryMedical deviceLocal areaWorldwideFlexible hours
- ...surgery. If you're ready to contribute to something bigger... ...Work in a cross-functional project team to design and develop... ...within your area; support regulatory and standards compliance activities... ...engineering experience (medical device industry preferred)....RegulatoryMedical deviceLocal areaWorldwideFlexible hours
$50 - $60 per hour
...primarily focusing on software and medical device projects rather than pharmaceuticals... .... Track and maintain regulatory documentation and ensure... ...delinquencies in a timely manner, coordinating with internal teams and... ..., properly uploaded, and ready for submission, coordinating...RegulatoryMedical deviceHourly payContract workTemporary workFlexible hours$47.15k - $76.71k
...schedules, and maintaining compliance with medical device regulations. Responsibilities Perform... ...to ensure adherence to workmanship and regulatory standards. Support manufacturing... ...calibration status, and ensuring material readiness—including accurate material transactions...RegulatoryMedical deviceLocal areaFlexible hoursShift work- ...potential to change a life.If you’re ready to contribute to something... .... In collaboration with Medical Office and Product Management... ...Product Management, Quality, Regulatory) to define product requirements... ...plus15+ years in the medical device industry.10+ years in...RegulatoryMedical deviceFull timeWork at officeLocal areaWorldwideFlexible hoursShift work
- ...change a life. If you're ready to contribute to... ...and managing a diverse project portfolio to ensure that... ...highest standards for regulatory submissions and scientific... ...journals, and medical conferences. Explore novel... ...trials, surgical medical device clinical research strongly...RegulatoryMedical deviceLocal areaWorldwideRelocationFlexible hours
- ...outcomes research studies to help regulatory approvals and key strategic... ...patient recruitment and projections, creation of study related... ...and ensure sponsor audit readiness Liaise with external... ...implementing, helping and managing medical device trials Significant...RegulatoryMedical deviceInterim roleLocal areaRemote workFlexible hoursShift work
- ...Product Development team focused on robotic-assisted platforms in China. This role involves collaborating with design teams and regulatory bodies to ensure successful product launch and compliance. The candidate will be responsible for technical contributions to the product...RegulatoryMedical device
- ...in Sunnyvale, CA to champion user-centered design and lead usability projects. This role will integrate human factors principles across product development to enhance usability, safety, and regulatory compliance. Candidates should have a background in Human Factors Engineering...RegulatoryMedical device
$109k - $174.8k
...Senior Regulatory Affairs Program Lead Fueled by innovation... ...of surgery? Ready to join a team that's reimagining... ...for specifications, device testing, risk... ...communicate timelines for project completion, and address... ...Affairs experience within Medical Device is required (4+...RegulatoryMedical deviceWork at officeLocal areaRelocation packageFlexible hours3 days per week- ...Sunnyvale, CA, to lead procurement efforts and ensure material readiness. You will work across various teams to support SIOP alignment... ...degree and a background in regulated industries, preferably medical devices. Travel may be required for supplier site visits, and the...Medical device
$100k
...Clinical Specialist for Shockwave Medical Inc. located in the North Bay... ...personalized treatments. Ready to join a team that’s... ...standard of care for medical device treatment of atherosclerotic... ...Clinical Practice (GCP) and regulatory compliance guidelines for clinical...RegulatoryMedical deviceFull timeTemporary workLocal areaRemote workRelocation- ...suppliers, and internal R&D builds Complete projects at a rapid pace consistent with program... ...Experience: At least 5 years of medical device industry experience Contract... ...standard and regulations, Quality Assurance, Regulatory Affairs, and Clinical Affairs...RegulatoryMedical deviceOngoing contractContract workFor subcontractorFlexible hours
- .... You will define manufacturing KPIs, lead scale-up operations, and ensure compliance with regulatory standards. The ideal candidate has 5+ years of experience in medical device manufacturing, a strong foundation in design and assembly of electromechanical systems, and...RegulatoryMedical device
- ...meaningfully with investigators, coordinators, and clinical events... ...management (CRM) devices or equivalent... ...quality, timelines, and regulatory outcomes. Studies are... ...participate in audit readiness activities, such as maintaining... ...of experience in the medical device industry...RegulatoryMedical deviceContract workWork at officeRemote workNight shift
$35 - $40 per hour
...junior team members, coordinates work with vendors and... ...to support facility projects and specialized work.... ...applicable building codes and regulatory requirements relevant... ...and parts to ensure readiness for maintenance and... ...a manufacturing or medical device environment is...RegulatoryMedical devicePermanent employmentContract workTemporary workFor contractorsMonday to FridayDay shift
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