Manager, Regulatory Compliance

Abbott • Plano, TX

2d • Onsite

About The Position

The Regulatory Compliance Manager is responsible for ensuring the organization’s medical devices comply with applicable global regulatory requirements and industry standards throughout the product lifecycle. This role oversees compliance programs, recalls/field actions, drives regulatory intelligence, drives implementation of regulatory and standards changes across the organization to maintain quality system and product compliance. Regulatory Compliance Manager also supports the quality system by taking action to align activities with Corporate Compliance objectives.

Requirements

• Associate’s degree
• Minimum of 7 years of relevant experience
• Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups facilitates others' participation in the continuous improvement program
• Investigates and solves problems that impact work processes and personnel within or across units or departments
• Develops and communicates a vision for the organizational unit assigned

Nice To Haves

• Bachelor’s degree preferred.
• Minimum of 2- 3 years of people management
• Strong understanding of regulatory requirements and QMS standards
• Confidently communicate with regulators, auditors, and leadership
• Project and program management skills
• Excellent communication and stakeholder management
• High attention to detail and organizational skills

Responsibilities

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Ensure ongoing compliance with FDA regulations (21 CFR Parts 803, 806, 820), EU MDR/IVDR requirements, and applicable global regulations.
• Monitor and assess global regulatory requirements and product standards (e.g., FDA, EU MDR/IVDR, ISO 13485, ISO 14971).
• Establish processes for regulatory intelligence gathering and impact analysis.
• Evaluate the impact of regulatory and standard updates on existing products, processes, and quality systems.
• Lead implementation of regulatory and standards changes, ensuring alignment with internal processes.
• Communicate changes to stakeholders and provide guidance on compliance requirements.
• Translate regulatory requirements into actionable project plans.
• Monitor project timelines, risks, and deliverables to ensure compliance and timely execution.
• Support internal and external audits, including regulatory inspections.
• Develop and maintain policies, SOPs, and work instructions related to recalls and regulatory updates.
• Lead and manage product recalls, field corrections, and safety notices in compliance with FDA (21 CFR Part 806), EU MDR, and other global regulations.
• Perform health hazard evaluations (HHEs) and risk assessments to support escalation decisions.
• Interface with regulatory authorities and notified bodies as needed.
• Ensure timely reporting to regulatory authorities (e.g., FDA, EMA, Health Canada, MHRA).
• Monitor recall effectiveness and conduct recall effectiveness checks.
• Track and report compliance metrics and KPIs to leadership.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Associate degree