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.

Location: Lake Forest, IL

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with 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.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity:

MAIN PURPOSE OF ROLE

Our Diagnostics Division currently has a full-time opportunity for an Associate Director – Regulatory Affairs.

This position is based at Abbott’s Conway Park Office in Lake Forest, IL.

The Associate Director – Regulatory Affairs is a lead SME role for the Hematology Application Specialist area within the Hematology Global Service organization. They will implement and coordinate advanced Hematology application programs that improve Global Service and instrumentation operation and performance. The candidate is able to lead and coordinate between the Area Hematology Apps groups globally at a senior / managerial level. The candidate is a recognized SME with significant experience, who is considered an expert across the division and across functions.

What You’ll Work On:

MAIN RESPONSIBILITIES

• Working with Dept. Manager assists in developing and leading Global Service Hematology Application support functions.
• Participates in strategy development and the translation of strategy into specific actions at a global managerial level Responsible for leading creation of technical service and support documentation including ISAs, TSBs, Knowledge Management, Hematology documentation, customer operations documentation and other service troubleshooting and customer guidance documentation.
• Reviews, originates, generates, and approves technical and design control / quality documentation including technical manuals, Change Records, instrument design specifications and label copy.
• Lead projects to improve service and support documentation processes for Hematology.
• Assists Manager in developing service/applications or support strategies for new product launches and revising service and support strategies for on-market products.
• Leads implementation of strategy (Includes service cost analysis, parts stocking recommendations, remote diagnostics strategies, life-cycle planning, voice of the customer issues etc.) Works closely with Marketing and Medical Affairs to identify, develop, and lead complex projects for the implementation of new Hematology applications and support tools, parts and procedures to reduce service costs globally and increase customer satisfaction.
• Acts as senior project team leader on cross-functional projects.
• Develops and is accountable for project timelines and deliverables.
• Can be delegated supervisory responsibility when manager is absent.
• May lead and manage field teams providing specialist Level 3 Hematology Applications Support including remote / on-site support as required This position also trains and develops others in the theoretical principles and practical application of Hematology Applications.
• Advances the level of technical Hematology expertise within the division.
• Travel: less than 10%

Accountability/Scope:

• They will assist the department manager with establishing department goals and coordinating plans to achieve these goals, directing junior staff as required.
• Provides direction to other department / team personnel.
• Mentors junior personnel.
• They are able to represent Global Service and Hematology Applications support at divisional meetings, and on LEAD projects and internal improvement teams.
• Specifies the resources required for the completion and implementation of technical projects.
• Reviews project plans, timelines, progress towards goals, and evaluates results.
• Recommends resource allocations and changes project scope to achieve broad objectives.
• Interacts with the following groups: hardware engineering, software development, systems integration, reagent development, supply chain, medical affairs, quality, regulatory, informatics and both field-based and internal service personnel, marketing and commercial personnel.
• In addition, this role may also require interfacing with OEM engineering vendors.
• Will require interaction with cross divisional personnel as required.

Preferred Qualifications:

• Master’s Degree or Ph.D. (e.g., biology, chemistry, etc.)
• 10 years’ regulatory affairs experience from FDA, which includes 510k, PMA submissions experience.

Required Qualifications:

Education:

• Minimum: Associates Degree or equivalent certification in Science, Engineering, allied health or scientific or engineering related field
• Preferred: BS Degree in Medical Technology, Bio-Engineering or related field.

Experience:

• Minimum 10 years of work experience in clinical laboratory, biomedical engineering, diagnostic medical equipment servicing, or related service or laboratory field.
• Preferred experience will be in a Hematology lab environment.

The candidate is able to lead and coordinate multiple projects at a managerial level, is a recognized SME with significant experience and influence, and is considered an expert across the division and across functions.