Regulatory Operations Compliance Project Manager - Medical Devices (on-site)

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 114,000 colleagues serve people in more than 160 countries.

• Lead procedural updates and emerging regulation implementation working with cross BU/cross functional teams
• Develop new regulatory policies, processes and SOPs
• Facilitate procedure implementation
• Provide strategic input and technical guidance on regulatory requirements for process decisions
• Evaluate regulatory risks of division policies, processes, procedures
• Develop and mentor regulatory professionals
• Drive change order activities
• Create supplemental training materials
• Review and follow document quality system structure
• Lead team meetings and document meeting minutes
• Work on process workflow development teams collaborating with Abbott IT system enhancement teams
• Author communications and presentations for upper management

• Bachelor's Degree in a related field OR an equivalent combination of education and work experience
• Minimum 4 years' experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area
• Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences
• Domestic and international regulatory guidelines, policies and regulations
• Lead functional groups in the development of relevant data to complete a regulatory submission

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit
• 401k matching
• Health insurance
• Flight privileges

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 114,000 colleagues serve people in more than 160 countries.