Job Description

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

• Bachelor's degree in engineering, life sciences, or a related field.
• Minimum of 5 years of project management experience in the medical device industry.
• Demonstrated experience managing projects through design verification (DV) .
• Proven experience with 510(k) and/or PMA submissions .
• Experience with catheter-based products is highly preferred.
• Strong understanding of FDA regulations and ISO 13485 .
• Experience with supplier relations and management .
• Excellent leadership, communication, and organizational skills.
• Project Management Professional (PMP) certification is a plus.

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