Manager, Regulatory Compliance

Responsibilities

• Ensure medical device compliance with global regulatory requirements and industry standards throughout the product lifecycle
• Oversee compliance programs, including product recalls, field corrections, and safety notices
• Monitor and assess global regulatory requirements such as FDA, EU MDR/IVDR, ISO 13485, and ISO 14971
• Lead the implementation of regulatory and standards changes across the organization
• Perform health hazard evaluations (HHEs) and risk assessments to support escalation decisions
• Interface with regulatory authorities and notified bodies to ensure timely reporting
• Support internal and external audits and regulatory inspections
• Develop and maintain policies, SOPs, and work instructions related to recalls and regulatory updates

Requirements

• Associate’s degree
• Minimum of 7 years of relevant experience
• Knowledge of FDA 21 CFR Parts 803, 806, and 820
• Knowledge of EU MDR/IVDR requirements
• Knowledge of ISO 13485 and ISO 14971 standards
• Ability to investigate and solve problems impacting work processes and personnel

Preferred Qualifications

• Bachelor’s degree
• 2-3 years of people management experience
• Strong understanding of regulatory requirements and QMS standards
• Excellent communication and stakeholder management skills
• Proven project and program management skills

Benefits

• Career development opportunities within an international company
• Health Investment Plan (HIP) PPO medical coverage options
• Retirement savings plan with high employer contribution
• Tuition reimbursement and student debt assistance programs
• Access to FreeU education benefits for bachelor's degrees

About the Company

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, including diagnostics, medical devices, nutritionals, and branded generic medicines. With over 115,000 colleagues serving people in more than 160 countries, we are dedicated to advancing innovative technologies that help manage and treat life's greatest health challenges.