Principal Project Manager

Johnson & Johnson

. Develops and maintains schedules and priorities for Technical Documentation and Change Notification submissions to Notified Bodies under Regulation (EU) 2017/745 (MDR) .

Posted 10/16/2026full-timeZuchwil • SwitzerlandLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in project management within the medical device industry, focusing on regulatory affairs and compliance with European Medical Device regulations. Proficient in managing cross-functional projects, stakeholder communication, and utilizing project management tools to enhance processes and ensure timely submissions.

Highest-signal resume keywords

Project ManagementRegulatory AffairsMedical Device Industry ExperienceStakeholder ManagementMS Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Project PlanningSchedulingOrganizational SkillsRegulatory FilingsQuality Systems UnderstandingNew Product Development SupportProduct Lifecycle ManagementRisk Identification and MitigationCross-Functional Project ManagementEnglish Proficiency

Soft Skills

Communication SkillsCollaboration SkillsRelationship BuildingPresentation SkillsAbility to Manage Multiple Priorities

Tools & Technologies

Project Management ToolsCollaboration ToolsMS Office

Certifications & Qualifications

Project Management Professional (PMP)

Industry Keywords

European Medical Device RegulationNotified BodiesChange NotificationsTechnical DocumentationRegulatory Framework

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

Develops and maintains schedules and priorities for Technical Documentation and Change Notification submissions to Notified Bodies under Regulation (EU) 2017/745 (MDR)
Coordinates activities concerned with submissions to EU Notified Bodies, including applications and project tracking for new product introduction and 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
Identifies project risks and issues, implements mitigation plans, and escalates as appropriate
Coordinates maintenance of MDR Certificate data and associated documentation
Represents DePuy Synthes as point of contact for interactions with EU Notified Bodies regarding MDR applications, change notifications, TD Assessments, and recurring project and business meetings
Establishes accountability for preparation of outlines, summaries, status reports, memos, graphs, charts, tables, and slides
Interacts with EU regulatory agency personnel to expedite submission and approval of applications as necessary
Facilitates relationship building and maintenance with Notified Bodies by coordinating recurring connections
Consults with business unit personnel to establish and prepare priorities for EU regulatory filings for product approvals
Supports 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 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 in 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 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
Employee benefits plans (anticipated to be governed by DePuy Synthes following the planned separation)