Recall Project Manager – Medical Device

Aston Carter

8d•$42 - $50•Hybrid

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.

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.

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.