pAt Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. /p pAs guided by Our Credo, Johnson Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit. /p h3Job Function /h3 pProject/Program Management Group /p h3Job Sub Function /h3 pProject/Program Management /p h3Job Category /h3 pProfessional /p h3All Job Posting Locations /h3 pBlackpool, Lancashire, United Kingdom, Leeds, West Yorkshire, United Kingdom, Oberdorf, Basel-Country, Switzerland, Ringaskiddy, Cork, Ireland, West Yorkshire, England, United Kingdom, Zuchwil, Switzerland /p h3Job Description /h3 h3About Orthopedics /h3 pFueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. /p pAre you passionate about improving and expanding the possibilities of Orthopedics? Ready to join a team that’s reimagining how we heal? Our Orthopedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. /p pYour unique talents will help patients on their journey to wellness. Learn more at /p pWe are searching for the best talent for a Principal Project Manager role. /p h3Purpose /h3 pThe bPrincipal Project Manager /b develops and maintains schedules and priorities for Technical Documentation and Change Notification submissions to Notified Bodies under Regulation (EU) 2017/745 (MDR). Serving as DePuy Synthes’ primary point of contact for project planning and execution with Notified Body counterparts, this role provides business teams and Notified Body representatives with clear direction to support timely reviews and achievement of franchise goals. /p h3You Will Be Responsible For /h3 ul liCoordinates activities concerned with submissions to EU Notified Bodies including applications and project tracking for new product introduction as well as for changes to existing products. /li liLiaises with business units to ensure appropriate execution of submissions. /li liDevelops and maintains detailed project plans, timelines, and status reports for stakeholders and leadership. /li liIdentify project risks and issues, implement mitigation plans, and elevate as appropriate. /li liCoordinates maintenance of MDR Certificate data and associated documentation. /li liRepresents DePuy Synthes as point of contact for interactions with EU Notified Body with regards to MDR applications, change notifications, TD Assessments and for recurring project and business meetings. /li liEstablishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. /li liInteracts with EU regulatory agency personnel in order to expedite submission and approval of applications as necessary. /li liFacilitates relationship building/maintenance with Notified Body by coordinating recurring connections (e.g. weekly, monthly, annual face-to-face meetings) /li liConsults with business unit personnel to establish and prepare appropriate priorities for EU regulatory filings for product approvals. /li liSupports continuous improvement initiatives by identifying opportunities to enhance processes, systems, and project management practices. /li /ul h3Qualifications And Requirements /h3 h3Education /h3 ul liBachelor’s degree required in project management, regulatory affairs, life sciences, engineering, or a related scientific discipline. /li liMaster’s degree preferred. /li /ul h3Required /h3 ul liTypically requires 5–8 years of experience in project management, preferably within Medical Device industry /li liProven experience managing cross functional projects in a medical device, or regulated environment /li liStrong project planning, scheduling, and organizational skills /li liAbility to manage multiple projects simultaneously and meet established deadlines /li liStrong communication, collaboration, and stakeholder management skills /li liProficient in MS Office /li /ul h3Preferred /h3 ul liExperience in supporting new product development and/or product lifecycle management for medical devices. /li liPrevious experience in project management within a regulatory framework (e.g. submission projects with Notified Body) /li liSolid understanding of European Medical Device framework, and quality systems /li liUnderstanding of preparing, submitting, and maintaining regulatory filings and approvals. /li liExcellent written, verbal and presentation skills including experience presenting at meetings with Regulatory Authorities. /li liExperience working with global Regulatory Affairs teams and aligning local activities with global strategies. /li liExperience using project management and collaboration tools /li liDemonstrated ability to manage multiple priorities in a fast‑paced environment. /li /ul h3Other /h3 ul liLanguages: English (written and verbal) required. German (written and verbal) is a plus. /li liCertifications: Project Management Professional (PMP) or similar certification preferred /li /ul pJohnson Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. /p pShould you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes, and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. /p #J-18808-Ljbffr
Principal Project Manager Arbeitgeber: Brighter Signals
Johnson & Johnson ist ein hervorragender Arbeitgeber, der eine inklusive und dynamische Arbeitsumgebung bietet, in der Teamgeist und Innovation geschätzt werden. Mit einem strukturierten Einarbeitungskonzept, vielfältigen Karrieremöglichkeiten und einer attraktiven Vergütung, einschließlich Bonuszahlungen und umfangreichen Gesundheitsbenefits, fördert das Unternehmen aktiv die persönliche und berufliche Entwicklung seiner Mitarbeiter. In der Region Norderstedt profitieren Sie von einem starken Netzwerk und der Möglichkeit, an der Spitze der MedTech-Innovation zu arbeiten, während Sie gleichzeitig Teil eines Teams sind, das Erfolge gemeinsam feiert und eine positive Fehlerkultur lebt.
