MedTech experience Project Manager

Overview

On Site
Depends on Experience
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - 6 Month(s)
No Travel Required

Skills

Design Control
21 CFR
Onsite role to CA

Job Details

Key Responsibilities:

  • Manage and oversee multiple projects across the MedTech portfolio, ensuring alignment with organizational goals and regulatory requirements.

  • Implement and maintain Design Control processes throughout the product development lifecycle.

  • Ensure project documentation and activities comply with 21 CFR Part 820, ISO 13485, IEC 62304, and ISO 14971 standards.

  • Coordinate with cross-functional teams including R&D, Quality, Regulatory Affairs, and Manufacturing to ensure project milestones are achieved.

  • Develop and maintain project plans, schedules, risk assessments, and resource allocation strategies.

  • Monitor progress, identify risks, and implement corrective actions to keep projects on track.

  • Report on project status, deliverables, and KPIs to leadership and key stakeholders.

  • Facilitate project meetings and support business-critical onsite discussions as required.

Required Qualifications:

  • Bachelor s degree in Engineering, Life Sciences, or a related technical discipline (Master s preferred).

  • 8+ years of experience in project or portfolio management within the Medical Device or MedTech industry.

  • Strong understanding and practical experience with Design Controls and 21 CFR regulations.

  • Working knowledge of ISO 13485, IEC 62304, and ISO 14971 standards.

  • Proven ability to manage cross-functional teams and drive project execution in a regulated environment.

  • Excellent communication, leadership, and stakeholder management skills.

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