Regulatory Affairs Manager

Abbott; Lake Forest (IL); Vor Ort; USD 99.000 - 199.000; Vollzeit

Zusammenfassung

Abbott, located in Lake Forest, IL, seeks a Regulatory Affairs Manager to guide advertising and promotional materials across U.S. and global marketing initiatives for diagnostics and medical devices.

The role emphasizes collaboration with cross-functional teams, development of regulatory strategies, and risk mitigation throughout product lifecycles, without handling market authorization submissions.

Qualifikationen

• Bachelor’s degree required; 4-5 years’ experience in a regulated industry.
• Experience in regulatory review of advertising and promotional materials, including digital communications.
• Familiarity with medical devices, IVDs, Digital Health, and global regulatory strategies preferred.

Aufgaben

• Provide regulatory input to product lifecycle planning.
• Review promotional materials for regulatory and labeling compliance.
• Develop multi-country regulatory strategies and communicate risk mitigation.
• Offer guidance to regional affiliates on advertising, digital and external communications.
• Collaborate cross-functionally to support compliant communications across markets.
• Contribute to continuous improvement of regulatory review processes.

Kenntnisse

Regulatory knowledge

Regulatory affairs

Ausbildung

Bachelor’s degree in science or related

M.S. or MBA preferred

Jobbeschreibung

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 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

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. You’ll 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 bachelor’s 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. We’re 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 Abbott’s diagnostics instruments, providing lab results for millions of people.

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 You’ll 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

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

Preferred Qualifications

• Bachelor’s 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: IVD’s, Clinical Chemistry, and/or Pharmacology.

The base pay for this position is

$99,300.00 – $198,700.00

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

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/

Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

JOB FAMILY:

Regulatory Operations

DIVISION:

CRLB Core Lab

LOCATION:

United States > Lake Forest : CP01

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

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: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf