Regulatory Affairs Manager

Responsibilities

• Provide end-to-end regulatory support to ensure compliant business processes and international compliance operations for the Diabetes Care division
• Lead SOP and work instruction development, review, and implementation
• Provide regulatory input to product lifecycle planning and regional regulatory strategies
• Identify market-access and cross-border regulatory considerations to proactively flag potential obstacles
• Determine and communicate submission and approval requirements for various global markets
• Lead cross-functional team reviews, documenting decisions and coordinating change implementation
• Monitor the impact of changing regulations on submission strategies and translate changes into practical guidance
• Assist with label development and review for compliance before release
• Maintain expert working knowledge of laws and regulations related to QA, manufacturing, and R&D

Requirements

• Bachelor's degree or an equivalent combination of education and work experience
• Minimum 8 years of experience in the medical device industry
• At least 5 years of experience related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class I, II, and III medical devices
• Proven scientific writing experience
• Working knowledge of QSR, ISO, and EN standards
• Strong understanding of regulatory requirements for the European community, Japan, Canada, and other international markets
• Strong organizational and communication skills with the ability to manage multiple competing priorities

Preferred Qualifications

• Bachelor's degree in a medical, science, or engineering-related discipline
• Advanced degree such as MS, PhD, PharmD, or MBA
• Experience with international regulations including ANVISA, TGA, NMPA, and EU (MDR/IVDR)
• Experience with design controls in medical devices or the pharma industry
• Proficiency with Veeva Vault or experience applying AI-assisted technologies for process improvement
• Experience building automations or dashboards to present information to leadership
• Professional certifications such as RAC, PMP, or Lean/Six Sigma

Benefits

• Career development opportunities within a global international company
• Eligibility for free medical coverage via the Health Investment Plan (HIP) PPO plan
• Excellent retirement savings plan with high employer contributions
• Tuition reimbursement and specialized student debt and education programs

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, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.