Job Description
About the position Join a dynamic team as a Recall Project Manager in the medical device sector. This is a full-time, 8-month contract position that offers a hybrid work environment in Lebanon, TN, requiring a minimum of three days onsite each week. This role demands a seasoned project manager with extensive experience in regulatory compliance and the ability to lead cross-functional initiatives under tight deadlines. Ideal candidates will have between 5 and 8 years of project management experience in the medical device industry, specifically handling recalls or similarly critical projects.
Responsibilities • Monitor and track the progress of field actions, ensuring timely and effective completion. • Collaborate with regional and country field action coordinators to ensure global execution. • Ensure timely submission of recall notifications and responses to customers. • Provide clear and concise communication to internal and external stakeholders regarding field actions and product recalls. • Coordinate periodic recall meetings with stakeholders and provide regular updates/metrics to management on progress.
• Work with cross-functional teams (QA, Legal, Supply Chain, Sales, Customer Service) to manage recall operations and logistics. • Maintain accurate and detailed records of field actions and associated activities. • Ensure monthly reports are submitted to Health Authorities, when required. • Work with finance to ensure recall expenses align with budget. • Develop and maintain detailed project plans, timelines, and deliverables for the recall process. • Ensure adherence to regulatory standards and internal compliance requirements.
• Identify potential risks and implement mitigation strategies to ensure patient safety and regulatory compliance. • Maintain accurate project documentation, including risk assessments, compliance reports, and stakeholder updates. • Prepare status reports for leadership and regulatory bodies as required. • Serve as the primary point of contact for internal teams and external partners. • Provide timely updates and ensure alignment on project goals and timelines. Requirements • Bachelor’s degree in Business Administration, Healthcare, or a related field.
• 4+ years of project management experience, preferably in medical device recalls or regulated industries. • Strong understanding of FDA recall procedures and industry standards. • Expertise in risk management, regulatory compliance, and quality systems. • Proficiency with project management tools (MS Project, Smartsheet, Monday.com). • Excellent organizational, communication, and leadership skills. Nice-to-haves • PMP certification preferred. • Bachelor’s degree in Engineering, Life Sciences, Business Administration, Healthcare, or related field.
• Stakeholder management skills. Benefits • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Apply tot his job