- Company Name
- CardiaCare
- Job Title
- Vice President / Head of operations
- Job Description
-
Job Title: Vice President / Head of Operations
Role Summary
Executive leader responsible for end‑to‑end operational excellence across clinical, regulatory, R&D, manufacturing, and business functions. Drives execution of projects, budgets, and strategic priorities while ensuring regulatory compliance and scalability.
Expectations
* Achieve ≥90% on‑time milestone completion across all major workstreams.
* Implement and maintain enterprise‑wide operational systems (ERP, QMS, inventory, doc mgmt).
* Provide weekly, monthly, quarterly, and annual KPI reporting to executive leadership and Board.
* Lead cross‑functional alignment and serve as operational hub for the senior leadership team.
* Expand manufacturing readiness, supply chain capability, and vendor qualification for scale‑up in line with ISO 13485 and FDA requirements.
Key Responsibilities
* Drive company‑wide execution across clinical, regulatory, R&D, and manufacturing functions.
* Establish integrated project plans, track progress, and mitigate risks using tools such as Jira, Smartsheet, or equivalent.
* Monitor and manage functional budgets; optimize resource allocation.
* Implement scalable operational systems supporting clinical, regulatory, and manufacturing workflows.
* Champion cross‑functional communication and collaboration.
* Oversee manufacturing transition from prototype to scalable production: supplier qualification, vendor audits, and ISO 13485/FDA compliance.
* Support clinical and regulatory milestones, ensuring timely documentation and approvals.
* Resolve operational roadblocks directly and maintain project momentum.
* Design and deploy tools, processes, and reporting mechanisms that enhance operational efficiency.
* Foster a hands‑on, accountable culture and mentor teams to embrace urgency.
Required Skills
* 5–7+ years of operational leadership in medical devices, covering clinical, regulatory, and manufacturing.
* Proven program and project management success with multi‑functional teams; expertise with Jira, Monday, Smartsheet, or equivalent.
* Strong business acumen, resource and budget stewardship in fast‑paced, resource‑constrained environments.
* Hands‑on problem solving and execution mindset.
* Excellent interpersonal, communication, and stakeholder‑management abilities.
* Knowledge of ISO 13485, FDA device regulations, and clinical trial operations.
* Experience in cardiac or electrophysiology devices is preferred.
Required Education & Certifications
* Bachelor’s degree in Engineering, Science, Business Administration, or related field (Master’s preferred).
* Medical device industry experience is mandatory; certification such as PMP, CPIM, or CQE is advantageous.
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Los angeles, United states
On site
Senior
18-10-2025