Regulatory Affairs Specialist

Regulatory Affairs Specialist

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

• Career development with an international company where you can grow the career you dream of.

• 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 bachelors degree.

• A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity working mothers female executives and scientists.

The Opportunity
This position works out of our Lake Forest IL location in the Core Lab Diagnostics Division. Were empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day more than 10 million tests are run on Abbotts diagnostics instruments providing lab results for millions of people.

The Regulatory Affairs Specialist will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The Regulatory Affairs Specialist supports the global commercialization of In Vitro Diagnostic (IVD) devices by providing regulatory input across product development and launch lifecycles. This role partners closely with cross functional stakeholders to enable timely compliant and efficient market entry of internally developed or third-party products distributed by the organization. The position requires strong project planning communication skills and a proactive mindset focused on reducing regulatory barriers and improving processes. The individual must understand implement and maintain the quality policy and ensure compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

What Youll Work On

• Provide regulatory guidance and strategic input for projects involving the global commercialization of IVD devices.

• Collaborate with crossfunctional project teams including Marketing Commercial Quality Technical Regulatory Affiliates and ThirdParty Manufacturers.

• Support project planning activities by defining regulatory deliverables timelines and considerations that inform launch sequencing and global launch waves.

• Ensure regulatory and quality requirements are integrated into project plans and executed in accordance with internal procedures and applicable regulations.

• Oversee regulatory aspects of launching thirdparty manufactured products ensuring adherence to internal quality systems and distribution requirements.

• Act as a regulatory liaison between internal teams and external partners to facilitate alignment issue resolution and timely execution.

• Identify regulatory risks and barriers early in the project lifecycle and propose mitigation strategies to support accelerated commercialization.

• Drive continuous improvement by identifying opportunities to streamline regulatory processes improve crossfunctional workflows and address people process or system inefficiencies.

• Communicate regulatory expectations decisions and impacts clearly to project stakeholders at varying levels of the organization.

Required Qualifications

• Bachelors degree in scientific engineering or related discipline

• Minimum 5 years experience.

• Experience in Regulatory Affairs within the medical device and/or in vitro diagnostics industry.

Preferred Qualifications

• Masters degree preferred.

• Working knowledge of global regulatory frameworks applicable to IVD products.

• Demonstrated experience working in crossfunctional matrixed project environments.

• Strong project planning organizational and prioritization skills with the ability to manage multiple initiatives simultaneously.

• Excellent written and verbal communication skills with the ability to translate regulatory requirements into clear actionable guidance.

• Proven ability to identify process improvement opportunities and drive solutions that enhance efficiency and compliance.

• Collaborative proactive and detailoriented with a strong focus on execution and results.

• Experience supporting thirdparty or externally manufactured products.

• Exposure to global product launch planning and phased international rollouts.

• Familiarity with quality systems related to product commercialization and distribution.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives: your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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