R&D Project Lead
Katalyst Healthcares and Life Sciences
Job Summary:
- Provide R&D Lifecycle Management (LCM) support for the MDR franchise initiative to ensure successful closure of applicable Design History Files (DHF) and implementation of MDR-compliant product families across applicable Ethicon manufacturing sites.
- Support EUDAMED UDI data collection activities, collaborate with cross-functional teams, and ensure regulatory documentation is developed, approved, and maintained in compliance with project requirements.
- Provide R&D LCM support to the MDR franchise initiative to successfully close applicable Design History Files (DHF) leading to the implementation of MDR-compliant product families in applicable Ethicon manufacturing sites.
- Support manual data collection for EUDAMED UDI as per approved protocols and work with cross-functional teams for all Ethicon product families as required.
- Engage with cross-functional team members to ensure proper documentation is developed and approved in the PLM system.
- Escalate concerns, issues, or delays to Ethicon management as needed.
- Ensure completion of all assigned training courses within required timelines.
- Lead cross-functional project activities and support stakeholder communication.
- Support risk management, planning, and project execution activities.
- Work with regulatory databases and structured data submissions as required.
- Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or a related field.
- Experience in medical device R&D, regulatory, or quality roles.
- Proven experience leading cross-functional projects.
- Hands-on experience with EU MDR requirements.
- Exposure to EUDAMED submissions or data preparation is highly preferred.
- Experience with Pharmaceutical and Adaptiv is highly preferred.
- Strong understanding of EU MDR and medical device lifecycle requirements.
- Knowledge of Design Controls, Risk Management (ISO 14971), and Clinical Evaluation.
- Familiarity with UDI requirements and medical device data structures.
- Strong project management, problem-solving, and decision-making skills.
- Experience with project management and document management systems.
- Comfortable working with regulatory databases and structured data submissions.
- Excellent written and verbal communication skills.
- bility to work effectively in a matrix organization.
- Detail-oriented with a strong compliance mindset and collaborative approach.
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the R&D Project Lead in Raritan, NJ vacancy
- ...in Raritan, New Jersey is looking for a professional to provide R&D Lifecycle Management (LCM) support for the MDR franchise initiative... ...experience in medical device R&D and regulatory roles. Strong project management skills and familiarity with EU MDR requirements are...Suggested
- ...performed by the Clinical Science & Operations Platform (CSO) of client R&D. The Clinical Study Director (CSD) is the medical reference in... ...or at least appreciated.SCOPE All clinical studies related to projects in clinical development (excluding Clinical & Exploratory...SuggestedWork at officeLocal area
- ..., global, enterprise teams of internal and external professionals. Participate in the business planning activities (budgets, projects and resource planning). Interview, hire and manage outside contractors as required. Execute Vendor optimization strategies and...SuggestedFor contractorsWork experience placement
Procyon TS
Raritan, NJ5 days ago - DePuy Synthes, part of Johnson & Johnson, seeks a SI&D Project Lead to drive and coordinate strategic initiatives within the Velystm Enabling Tech Supply Chain. Located in Palm Beach Gardens, Raynham, West Chester, or Raritan, NJ, this role requires strong PMO skills to...Suggested
- Jobtailor is seeking a Library/Information Services professional to lead and deliver library and information services for Business... ...years in medical device/pharma libraries, expertise in regulatory requirements, and strong project management. #J-18808-Ljbffr JobtailorSuggested
- dancker is looking for a detail-oriented Construction Administrator in Somerville, NJ. In this role, you will manage project documentation, assist with scheduling, and support financial reporting. The ideal candidate has 3-5 years experience in construction administration...
- Turner Construction Company is seeking an experienced project leader to direct and coordinate day-to-day management on a high-profile project. You will supervise staff, manage budgets, schedules, and client relationships, and ensure QA/QC adherence. This is a traveling...
- Spectrum 360 A NJ Non Profit Corp. is seeking an experienced Project Manager to coordinate Educational Activities initiatives. You will... ...reporting, systems, and process streams. The EA Project Manager will lead planning, coordination, reporting, and task management for...
- GenScript USA Inc/ProBio Inc. is seeking a Construction Project Manager to lead interior renovations and facility fit-outs in Piscataway, NJ. The role focuses on planning, design coordination, execution, commissioning, and validation while minimizing operational disruption...
- Aditi Consulting in New Jersey is seeking an experienced Project Manager to lead multiple network and enterprise-wide initiatives. You will drive end-to-end project plans, coordinate diverse teams, and ensure on-time, on-budget delivery aligned with business outcomes. Responsibilities...
- Rutgers University is seeking a Research Associate to serve as a project manager for the Ellison and Brand labs. The role involves conducting laboratory and computational experiments, mentoring students and trainees, and contributing to scientific manuscripts. The position...Traineeship
- A technology solutions company in Raritan, NJ, is seeking a Project Manager to lead complex cloud infrastructure projects. The ideal candidate will manage project timelines and resources, ensuring compliance with standards while collaborating with various teams. Key qualifications...
- Robotics Process Automation, LLC is seeking an experienced professional to manage supply chain projects and new product launches. The ideal candidate will have a Bachelor's degree in Business Management or related fields and 6+ years of experience in the pharmaceutical...
- Colgate-Palmolive in Piscataway, New Jersey, seeks a Regulatory Affairs Project Manager to lead global regulatory submissions and maintain the Medical Device Quality Management System. You will manage cross-functional teams to ensure compliance while driving product innovation...
- Rutgers University is seeking a Sr. Facilities Project Manager for the Division of IP&O. You will coordinate, develop, design, and budget renovation projects across the university. You will oversee 5-15 projects in various stages of design and construction, require a Bachelor...Full time
- ...Jersey in Bernardsville, NJ seeks a Senior Restoration Crew Chief to own projects from inspection through completion. You will inspect losses, determine remediation protocols, develop field scopes, and lead technicians, communicating with homeowners and insurance...
- Conference Technologies, based in New Jersey, is seeking an experienced AV Project Manager to oversee all aspects of AV integration projects. You will coordinate resources, manage schedules, and maintain clear communication with clients and internal teams to ensure on-time...
$178k - $307.05k
...searching for the best talent for Senior Director, US CAR-T Operations Lead role to be in United States, NJ Raritan. Purpose The Senior... ..., Regulatory Affairs, Procurement, External Manufacturing, R&D, and Commercial teams. The successful leader will strengthen internal...Local areaImmediate start$110.71k - $145.3k
...cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative... ...seeking a Manager, CMO Operations - VMT Lead (Autologous CAR T) as part of the Global... ...transfers, and process improvement projects. Promote operational excellence, standardization...Permanent employmentFull timeContract workTemporary workFor contractorsLocal areaWorldwideFlexible hours- ...Innovative Medicine in New Jersey is seeking a Senior Director to lead US CAR-T Manufacturing Operations, partnering with Legend Biotech... ...therapies. You will lead an expanding organization, align with R&D, MSAT, Quality, Regulatory, and Commercial teams, and champion a...
- ...existing skill base, allow for flexibility in project planning and execution phases, and provide... ...trials.The Process Project Manager (PPM) leads/ participates in transversal projects... ...processes.Skills:An extensive knowledge of R&D, with past experience in clinical operations...Immediate startRemote work2 days per week
- ...existing skill base, allow for flexibility in project planning and execution phases, and provide... ....Job Description• The Global Feasibility Lead is accountable for the coordination and... ...Sciences Operation Platform (CSO) of Company’s R&D. • The objective of the feasibility...Local areaImmediate startFlexible hours
$122k - $212.75k
...recruiting for a(n) Sr. Manager, Portfolio Project Management, located in Raynham, MA,... ...across the organization. Key Responsibilities Lead and govern a portfolio of SC&O projects, ensuring... ..., Planning, Procurement, Quality, R&D, and Commercial) to drive on‑time, on‑budget...Full timeImmediate start$85k - $135k
...Summary The Falcon Group is seeking an experienced Building Envelope Specialist to support and lead projects involving evaluation, design, and remediation of exterior cladding and envelope systems across multifamily, commercial, and institutional buildings. This individual...Full timeFor contractorsLocal areaThe Falcon Group
Warren, NJmore than 2 months ago- ...Project Manager IIIThe Project Planning Manager is responsible for managing the planning... .... For each of his/her project, he/she is leading and coordinating operational planning actors... ...each project they are assigned from the R&D portfolio in the Planisware planning system...Local area
Hire Talent
Bridgewater, NJ7 hours ago - ...Project ManagerProvides tools and methods and aligns cross-functional plans for the management... ...Managers, Project Managers and Project Leads. Monitors team progress and holds team members... ...teams with representatives from R&D, Quality, Regulatory, Tech Transfer, Compliance...
Careers Integrated Resources Inc
Raritan, NJ2 days ago $150k - $258.75k
...MedTech Distribution Center (DC) operations across the Americas (24+ sites, including owned sites and 3PL partner nodes). The role leads the delivery and lifecycle management of technologies that operate and automate >$13B in inventory and core DC operations, including...Full timeLocal areaImmediate start$45k - $80k
Presidential Exteriors in Piscataway, NJ is seeking a Project Manager for residential exterior remodeling. This in-person role offers a salary of $45,000-$80,000 plus performance incentives and full-time benefits. The PM will coordinate pre-install inspections, scheduling...Full timeLocal area- A design consultancy firm is seeking a Theatre Consultant / Project Manager to join their New Jersey team. The role involves designing theatres, collaborating on projects, and preparing documentation in Revit. Candidates should have a minimum of 5 years of theatre consulting...Full time
- A local staffing agency is seeking an experienced Land Surveyor - Project Manager to oversee land surveying projects including boundary and topographic surveys. This role requires a minimum of seven years of experience, preferably with a Professional Land Surveyor (PLS)...Local area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to R&D Project Lead. Be the first to apply!
Related searches
- project finance Raritan, NJ
- implementation project manager remote Raritan, NJ
- projects Raritan, NJ
- special projects Raritan, NJ
- software implementation project manager Raritan, NJ
- senior implementation project manager Raritan, NJ
- project controls Raritan, NJ
- project technician Raritan, NJ
- architectural project designer Raritan, NJ
- project lead