Project Manager

PROJECT MANAGER

We're seeking a Project Manager to join our team at a small, innovative Class III medical device company specializing in breakthrough MedTech products. The ideal candidate is a mid-level professional with a proven track record of managing projects through design verification (DV) and regulatory submissions, specifically with 510(k) and Pre-Market Approval (PMA) experience. This role will support all company programs, from early-stage development to post-market activities, and requires a candidate who is hands-on and adept at navigating the unique challenges of a dynamic startup environment.

Responsibilities

• Manage the entire project lifecycle for Class III medical devices, from initial concept through to commercialization and post-market surveillance.
• Lead cross-functional teams, including R&D, Quality, Regulatory Affairs, and Manufacturing, to ensure projects are delivered on time, within scope, and on budget.
• Develop and maintain detailed project plans, schedules, and budgets, while proactively identifying and mitigating potential risks.
• Oversee the design verification and validation processes, ensuring all activities are meticulously documented and meet regulatory requirements.
• Coordinate the creation and submission of regulatory filings, including 510(k) and PMA applications, in collaboration with the regulatory team.
• Manage supplier relationships and external partners, ensuring they meet project requirements and quality standards.
• Facilitate effective communication among all stakeholders, providing regular updates on project status and key milestones.
• Support the development and maintenance of quality system procedures related to project management.

Qualifications