drjobs Labelling Senior Project Manager (Medical Device & Regulatory Compliance) - Fulltime

Labelling Senior Project Manager (Medical Device & Regulatory Compliance) - Fulltime

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1 Vacancy
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Job Location drjobs

Aliso Viejo, CA - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Role: Labelling Senior Project Manager (Medical Devices & Regulatory Compliance)
Location: Aliso Viejo CA (Hybrid Onsite)
Job Type: Full Time
Required Skills:
Medical Devices Project Management Regulatory Compliance
Responsibilities:
  • Develop and drive the end-to-end project plan for eIFU adoption across global site.
  • Coordinate phase-in/phase-out strategy for paper and digital IFUs.
  • Manage cross-functional stakeholders including planning labeling regulatory procurement and supply chain.
  • Oversee change control documentation inventory coordination and sterilization impact assessments.
  • Ensure accountability risk tracking and timely execution of deliverables.
  • Integrate project workflows with existing systems; propose digital transformation solutions.
  • Report regularly to leadership; provide operational insights and escalation support.
Required:
  • Minimum 10 years of project management experience including preferably medical devices experience.
  • Deep knowledge of medical device regulations supply chain operations and change control processes.
  • Strong leadership communication and stakeholder engagement skills.
  • Experience with global teams and regulatory environments.
  • Familiarity with digital workflows labeling and documentation systems a plus.
  • PMP certification or equivalent preferred.

Employment Type

Full-time

Company Industry

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