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.