Recall Project Manager – Medical Device
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 Now
Apply Now
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 Now
Apply Now