Sr. Regulatory Affairs Manager at Abbott

Lake Forest, Illinois, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

Bachelor's Degree, preferably in scientific or engineering discipline
Ability to work 4-5 days a week in the office at Lake Forest, IL location
Willingness to travel up to 25% to Abbott locations potentially in and outside of the US

Responsibilities

Provide regulatory affairs project management for various areas, including 510(k), CLIA Waiver, label/advertising/promotional review, and other regulatory compliance activities
In collaboration with Regulatory leadership, develop and implement regulatory strategies to ensure earliest possible introduction of product(s) into domestic and international markets
Coordinate preparation of well-organized, complete, and scientifically sound regulatory submissions
Interface directly with various regulatory agencies to facilitate review and approval of regulatory applications
Exercise judgement within generally defined practices and departmental standard operating procedures
Develop and maintain strong and effective relations with internal/external personnel
Interact with regulatory agencies to expedite approval of pending registrations
Serve as regulatory liaison throughout product lifecycle
Participate in product plan development and implementation, regulatory strategy, and risk management
Serve as regulatory representative to marketing, research teams, and regulatory agencies
Advise development and/or marketing teams on manufacturing changes, technical labeling, appropriate regulations, and interpretations
Keep abreast of regulatory requirements in the US and countries where the Division intends to offer product for sale
Work with Regulatory leadership to prepare regulatory plan/strategy for product introductions
Manage the preparation of registration documents as required for international markets
Ensure that submissions are complete, properly formatted, and comply with applicable regulatory requirements
Make certain that appropriate documentation is maintained to record regulatory decisions made in design and development activities

Skills

Regulatory Affairs

Regulatory Compliance

Medical Devices

Diagnostics

Infectious Diseases

Global Regulatory

New Product Introductions

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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