Project Lead

Overview

• Drive MDR implementation projects remotely within the medical device industry, ensuring compliance and innovation across organizational functions.
• Coordinate cross-functional teams to achieve project milestones and deliverables efficiently and effectively.
• Provide expert guidance on MDR processes, leveraging technical and analytical expertise to support project success.
• Collaborate with engineering teams to review and finalize change orders and regulatory documentation.
• Ensure adherence to corporate policies and standards throughout project execution phases.
• Deliver comprehensive project updates and progress reports to stakeholders and suppliers.
• Utilize industry knowledge to enhance project management processes and outcomes.
• Contribute to the continuous improvement of MDR implementation strategies and methodologies.

Key Responsibilities & Duties

• Coordinate MDR project phases, including intake, planning, implementation, and closure, ensuring timely completion.
• Schedule and oversee label verification activities, collaborating with engineering teams for accuracy and compliance.
• Develop and implement project strategies aligned with program objectives and regulatory requirements.
• Monitor project milestones, identifying and addressing risks to maintain progress.
• Communicate effectively with stakeholders to share updates, address concerns, and align expectations.
• Generate purchase orders and manage interactions with external suppliers to support project needs.
• Stay informed on evolving MDR regulations and project management best practices.
• Enhance systems and processes to improve project efficiency and compliance outcomes.

Job Requirements

• Bachelor’s degree in life sciences, engineering, or business administration required.
• Minimum of 4 years of experience in MDR projects, with 6 years preferred.
• Proven background in manufacturing or quality engineering within medical device or pharmaceutical industries.
• Strong proficiency in project management methodologies and tools.
• Exceptional analytical and technical problem-solving skills.
• Effective communication and collaboration abilities with diverse stakeholders.
• Capability to independently manage complex projects and deliver impactful results.
• Knowledge of MDR regulations and implementation processes highly preferred.