Regulatory Affairs Manager

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 122000 colleagues serve people in more than 160 countries.

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 Manager provide regulatory review and strategic guidance for advertising and promotional materials and activities including digital customer-facing and external communications supporting U.S. and global marketing initiatives across medical devices in vitro diagnostics (IVDs) Digital Health solutions automation platforms software-enabled products and select non-medical products. Review and approve promotional materials to ensure compliance with applicable regulations approved labeling corporate policies divisional procedures and ethical business practices. Collaborate with cross-functional stakeholders to support product claims assess and mitigate regulatory risk and enable compliant communications throughout the product lifecycle. Note: Responsibilities for this position do not include product registration activities or regulatory submissions associated with obtaining market authorization.

What Youll Work On

• Provide regulatory input to product lifecycle planning.
• Combines scientific regulatory and business expertise to assess product claims evaluate regulatory risk and provide guidance that supports compliant product communications and business objectives.
• Reviews and aligns product communications with applicable regulations approved labeling corporate policies and divisional procedures to maintain compliance throughout all stages of the product lifecycle.
• Support the development maintenance and implementation of multi-country regulatory strategies as applicable.
• Utilize regulatory expertise to develop strategies and recommendations on complex regulatory issues.
• Identify and assess emerging regulatory issues and changes that may impact business activities.
• Provide regulatory guidance and support to regional and country Regulatory affiliates on advertising promotional digital and external communications activities as needed.
• Interpret and apply regulatory requirements company policies and divisional procedures to support compliant business activities.
• Communicate regulatory risks and recommend appropriate risk mitigation strategies to stakeholders.
• Support alignment and consistency of regulatory approaches for promotional and external communications across global regional and local markets as appropriate.
• Partners cross-functionally to support business needs while acting as a trusted regulatory resource providing expertise guidance and knowledge sharing to drive team and organizational success.
• Contribute to the continuous improvement of regulatory review processes procedures and training related to advertising and promotion activities.

Required Qualifications

• Bachelors Degree (or equivalent).
• 4-5 years experience in a regulated industry (e.g. medical products nutritionals).

Preferred Qualifications

• Bachelors degree in science (biology chemistry microbiology immunology medical technology pharmacy pharmacology) math engineering or medical fields is preferred.
• M.S. in a technical area or M.B.A. is preferred.
• Ph.D. in a technical area or law is helpful.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• Experience in regulatory preferred but may consider quality assurance research and 2-5 years of development/support scientific affairs operations or related areas.
• 2() years in Ad/Promo (Advertising / Promotions) regulatory experience with any of the following medical products: IVDs Clinical Chemistry and/or Pharmacology.

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

$99300.00 $198700.00

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

Regulatory Operations

CRLB Core Lab

United States > Lake Forest : CP01

Standard

Yes 10 % of the Time

Not Applicable

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: EEO is the Law link - Espanol: Experience:

Manager