What are the responsibilities and job description for the Labelling Senior Project Manager (Medical Device & Regulatory Compliance) - Fulltime position at Saransh Inc?
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
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.
- 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.
