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 4 days ago
Similar jobs that could be interesting for youBased on the R&D Project Lead in Raritan, NJ vacancy
- ...Provide R&D Lifecycle Management (LCM) support for the MDR franchise initiative to ensure... ..., and maintained in compliance with project requirements. Provide R&D LCM support to... ...close applicable Design History Files (DHF) leading to the implementation of MDR-compliant product...Suggested
Katalyst CRO
Raritan, NJ4 days ago - ...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 Sanofi R&D. • The Clinical Study Director (CSD) is the medical reference in... ...or at least appreciated.SCOPEAll 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, NJ4 days ago - 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
- 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...
- ...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...
- 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...
- 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...
$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- ...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
- ...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
$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$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- ...Project Manager III The Project Planning Manager is responsible for managing the planning... .... For each of his/her project, he/she is leading and coordinating operational planning... ...each project they are assigned from the R&D portfolio in the Planisware planning system...Local area
Hire Talent
Bridgewater, NJ4 days ago - 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
$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- BD in New Jersey seeks a Staff Engineer, Project Manager to lead eCTW projects ensuring on-time delivery and alignment with scope, schedule, and budget. The role requires coordination across plants, vendors, and cross-functional teams. The ideal candidate has a mechanical...
- 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
- Applegate is looking for a Senior Project and Portfolio Manager to oversee projects at their Corporate Office in Bedminster, NJ. This role involves leading a team to ensure successful delivery of various brand initiatives and managing the Governance Committee. The ideal...Work at office
- Consigli Construction Co. is seeking a full-time Project Manager in New Brunswick, NJ. This role involves serving as the main point of contact for all project stakeholders and overseeing the entire project lifecycle, ensuring budget management and adherence to timelines...Full time
- Legend Biotech USA is looking for an experienced Operations Associate to join the Technical Operations team in Raritan, NJ. This exempt position supervises the daily production of personalized cell therapy in a sterile cGMP environment, ensuring compliance and efficient...Work at office
- ...seeking a Facility Support Manager to oversee facility maintenance and ensure compliance with cGMP requirements. The role involves leading a team, managing maintenance activities, and participating in audits. Ideal candidates should have a Bachelor's degree in a relevant...
- Brother International Corporation, headquartered in Bridgewater, NJ, seeks a Senior Specialist, Export to manage orders in SAP for Latin America and Canada. You will prepare export documentation, ensure compliance with US customs, and coordinate with warehouses and forwarders...
- Specified Technologies is seeking a Senior Operations Manager to lead end-to-end operations, focusing on SIOP, planning, procurement, and logistics. This hybrid role is based in Somerville, New Jersey, where the candidate will ensure alignment between demand, supply, and...
- Legend Biotech in Raritan, NJ is seeking an Operations Supervisor for the Technical Operations team. This exempt position will oversee daily production in a cGMP environment, guide personnel, and ensure compliance with regulations. The successful candidate must have at ...
- Johnson & Johnson Innovative Medicine in New Jersey seeks an Associate Director, Global Medical Affairs Publication Operations to lead publication writing, strategy, and delivery of high-quality scientific materials for journals and meetings. You will oversee production...
- ...global biotechnology company is seeking an Operations Supervisor for its Technical Operations team in Raritan, NJ. This role involves leading the production of personalized cell therapies in a sterile cGMP environment. The ideal candidate will have a Bachelor's degree in...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to R&D Project Lead. Be the first to apply!
Related searches