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Job Function:
Project/Program Management GroupJob Sub Function:
Project/Program ManagementJob Category:
ProfessionalAll Job Posting Locations:
Blackpool, Lancashire, United Kingdom, Leeds, West Yorkshire, United Kingdom, Oberdorf, Basel-Country, Switzerland, Ringaskiddy, Cork, Ireland, Zuchwil, SwitzerlandJob Description:
About Orthopedics:
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Are 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.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
We are searching for the best talent for a Principal Project Manager role, to join our team located in Zuchwil, Switzerland.
Purpose: The Principal Project Manager 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.
You will be responsible for:
- Coordinates 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.
- Liaises with business units to ensure appropriate execution of submissions.
- Develops and maintains detailed project plans, timelines, and status reports for stakeholders and leadership.
- Identify project risks and issues, implement mitigation plans, and escalate as appropriate.
- Coordinates maintenance of MDR Certificate data and associated documentation.
- Represents 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.
- Establishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Interacts with EU regulatory agency personnel in order to expedite submission and approval of applications as necessary.
- Facilitates relationship building/maintenance with Notified Body by coordinating recurring connections (e.g. weekly, monthly, annual face-to-face meetings)
- Consults with business unit personnel to establish and prepare appropriate priorities for EU regulatory filings for product approvals.
- Supports continuous improvement initiatives by identifying opportunities to enhance processes, systems, and project management practices.
Qualifications and Requirements:
Education
- Bachelor’s degree required in project management, regulatory affairs, life sciences, engineering, or a related scientific discipline.
- Master’s degree preferred.
Experience and Skills
Required:
- Typically requires 5–8 years of experience in project management, preferably within Medical Device industry
- Proven experience managing cross functional projects in a medical device, or regulated environment
- Strong project planning, scheduling, and organizational skills
- Ability to manage multiple projects simultaneously and meet established deadlines
- Strong communication, collaboration, and stakeholder management skills
- Proficient in MS Office
Preferred:
- Experience in supporting new product development and/or product lifecycle management for medical devices.
- Previous experience in project management within a regulatory framework (e.g. submission projects with Notified Body)
- Solid understanding of European Medical Device framework, and quality systems
- Understanding of preparing, submitting, and maintaining regulatory filings and approvals.
- Excellent written, verbal and presentation skills including experience presenting at meetings with Regulatory Authorities.
- Experience working with global Regulatory Affairs teams and aligning local activities with global strategies.
- Experience using project management and collaboration tools
- Demonstrated ability to manage multiple priorities in a fast‑paced environment.
Other:
- Languages: English (written and verbal) required. German (written and verbal) is a plus.
- Certifications: Project Management Professional (PMP) or similar certification preferred
Johnson & 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.
Should 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.
#LI-AB6#LI-Hybrid
Required Skills:
Preferred Skills:
Skills Required
- Bachelor's degree in project management, regulatory affairs, life sciences, engineering, or a related scientific discipline
- 5-8 years of project management experience, preferably in the medical device industry
- Experience managing cross-functional projects in a medical device or regulated environment
- Strong project planning, scheduling, and organizational skills
- Ability to manage multiple projects simultaneously and meet deadlines
- Strong communication, collaboration, and stakeholder management skills
- Proficiency in Microsoft Office
- Master's degree
- Experience supporting new product development or medical device product lifecycle management
- Project management experience within a regulatory framework, including Notified Body submission projects
- Understanding of the European Medical Device framework and quality systems
- Understanding of preparing, submitting, and maintaining regulatory filings and approvals
- Experience presenting to regulatory authorities
- Experience working with global Regulatory Affairs teams
- Experience using project management and collaboration tools
- English written and verbal fluency
- German written and verbal fluency
- Project Management Professional (PMP) or similar certification
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
Johnson & Johnson Insights
What We Do
Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
