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Principal Project Manager
Johnson & Johnson. Develop and maintain schedules and priorities for Technical Documentation and Change Notification submissions to EU Notified Bodies under Regulation (EU) 2017/745 (MDR) .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in project management within the medical device industry, focusing on regulatory compliance and effective communication with EU Notified Bodies. Proficient in developing project plans, managing submissions, and facilitating stakeholder engagement.
Highest-signal resume keywords
Project ManagementRegulatory AffairsMedical Device Industry ExperienceStakeholder ManagementMS Office Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project PlanningSchedulingOrganizational SkillsRegulatory FilingsChange Notification ManagementRisk ManagementProduct Lifecycle ManagementQuality Systems UnderstandingCross-Functional Project ManagementEnglish Proficiency
Soft Skills
Communication SkillsCollaboration SkillsStakeholder EngagementRelationship BuildingPresentation Skills
Tools & Technologies
Project Management ToolsCollaboration ToolsMS Office
Certifications & Qualifications
Project Management Professional (PMP)
Industry Keywords
EU Notified BodiesRegulation (EU) 2017/745 (MDR)Medical Device FrameworkRegulatory ComplianceNew Product Development
Tech Stack
Tools & technologiesPMP
About the role
Key responsibilities & impact- Develop and maintain schedules and priorities for Technical Documentation and Change Notification submissions to EU Notified Bodies under Regulation (EU) 2017/745 (MDR)
- Serve as DePuy Synthes’ primary point of contact for project planning and execution with Notified Body counterparts
- Coordinate EU Notified Body submissions, including applications and project tracking for new product introductions and changes to existing products
- Liaise with business units to ensure appropriate execution of submissions
- Develop and maintain detailed project plans, timelines, and status reports for stakeholders and leadership
- Identify project risks and issues, implement mitigation plans, and escalate as appropriate
- Coordinate maintenance of MDR Certificate data and associated documentation
- Represent DePuy Synthes in interactions with EU Notified Bodies regarding MDR applications, change notifications, TD assessments, and recurring project and business meetings
- Establish accountability for preparation of outlines, summaries, status reports, memos, graphs, charts, tables, and slides
- Interact with EU regulatory agency personnel to expedite submission and approval of applications as necessary
- Facilitate relationship building and maintenance with Notified Bodies through recurring connections, including weekly, monthly, and annual face-to-face meetings
- Consult with business unit personnel to establish priorities for EU regulatory filings for product approvals
- Support continuous improvement initiatives by identifying opportunities to enhance processes, systems, and project management practices
Requirements
What you’ll need- Bachelor’s degree required in project management, regulatory affairs, life sciences, engineering, or a related scientific discipline
- Typically requires 5–8 years of experience in project management, preferably within the 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
- Experience supporting new product development and/or product lifecycle management for medical devices preferred
- Previous experience in project management within a regulatory framework preferred
- Solid understanding of the European Medical Device framework and quality systems preferred
- Understanding of preparing, submitting, and maintaining regulatory filings and approvals preferred
- Excellent written, verbal, and presentation skills, including experience presenting at meetings with Regulatory Authorities preferred
- Experience working with global Regulatory Affairs teams and aligning local activities with global strategies preferred
- Experience using project management and collaboration tools preferred
- Demonstrated ability to manage multiple priorities in a fast-paced environment preferred
- English (written and verbal) required
- German (written and verbal) is a plus
- Project Management Professional (PMP) or similar certification preferred
Benefits
Comp & perks- Inclusive work environment
- Benefit plans and employment programs (specific details subject to the planned separation and consultation processes)