Manager Regulatory Compliance - Recalls

Medline•Northfield, MN

10d

About The Position

This role is responsible for managing the recall team, providing coaching and development, and supporting the planning and execution of voluntary and mandatory recalls, product corrections, and removals in accordance with FDA regulations. The position contributes to recall and field action decisions, ensures timely submission of FDA documentation, and maintains compliance with relevant FDA regulations. It also involves supporting communications with the FDA, monitoring regulatory changes, tracking timelines, and facilitating cross-functional meetings.

Requirements

Bachelor’s Degree in Engineering, Science, or related field or Associates Degree with 3+ years experience
5+ years of experience in the medical device or pharma industry, experience with product recalls, complaints, non-conformances, CAPAs, or similar activities involving field action, root cause analysis and problem solving.
Experience with Microsoft Office Suite (Word, Excel, PowerPoint).
Experience with SAP.
At least 4 years of experience working with FDA/QSR/GMP/ISO requirements or other regulated industries.
At least 3 years of experience in recall management
Working knowledge of FDA regulations including 21 CFR Part 7, Part 806, Part 803, and ISO 13485
Experience supporting recall activities and regulatory submissions
Strong communication and project coordination skills
Experience supporting FDA audits or internal quality audits

Nice To Haves

5+ years of direct experience with recall management
Experience working in cross-functional regulatory or quality environments

Responsibilities

Manage the recall team, providing coaching and development for team members.
Support the planning and execution of voluntary and mandatory recalls, product corrections, and removals in accordance with FDA regulations.
Contribute to recall and field action decisions, including recall strategy recommendations.
Ensure timely submission of FDA Form 806 and related documentation, including status reports and termination requests.
Maintain compliance with 21 CFR Part 7 (Recall Policy) and 21 CFR Part 806 (Reports of Corrections and Removals).
Support communications with FDA and assist in preparing responses related to recalls.
Monitor regulatory changes related to field actions and adverse event requirements and escalate impacts to leadership.
Track timelines and ensure deliverables are completed on schedule; provide updates to leadership on progress and risks.
Facilitate and/or support cross-functional meetings to ensure alignment across stakeholders, including Quality, Regulatory, and Commercial teams.
Manages a team of individual contributors and/or supervisors.
Oversees day-to-day operations and execution of recall activities.
Supports development and execution of projects and program deliverables.
Implements and ensures adherence to established policies and procedures.
Provides direction and guidance to team members on processes and expectations.
Responsible for hiring input, performance management, and employee development.
Assigns work, monitors progress, and ensures consistency in application of organizational policies.
Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.