Regulatory Affairs Specialist II at Abbott

Pleasanton, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

(Not explicitly listed in the job description; inferred from context: experience in regulatory affairs, knowledge of international medical device regulations, ability to work cross-functionally)

Responsibilities

Authors, coordinates, compiles and submits international regulatory submissions, including filing and/or creation of Technical Documentation, Premarket Notifications, Supplements, Change Notifications, and other product registrations
Prepares robust regulatory applications to achieve departmental and organizational objectives
Represents RA on cross-functional product development and manufacturing support teams
Acts as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail
Maintains ongoing surveillance and analysis of all pertinent international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems
Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel
Interfaces directly with regulatory agencies as needed
Conducts reviews of product and manufacturing changes for compliance with applicable regulations
Communicates with and maintain productive, constructive relationships with external customers as required – regulatory authorities and notified-bodies
Support Department and Company initiatives as identified by management

Skills

Key technologies and capabilities for this role

Regulatory AffairsRegulatory ComplianceMedical DevicesFDA RegulationsQuality SystemsDocumentationGlobal Regulations

Questions & Answers

Common questions about this position

What benefits does Abbott offer?

Abbott provides free medical coverage in the Health Investment Plan (HIP) PPO medical plan, an excellent retirement savings plan with high employer contribution, tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit for earning a bachelor’s degree.

Is this position remote or on-site?

The role is based at the Pleasanton, CA location.

What are the main responsibilities of this role?

The position involves authoring, coordinating, compiling, and submitting international regulatory submissions, preparing robust regulatory applications, and representing RA on cross-functional product teams.

What is the company culture like at Abbott?

Abbott emphasizes doing work that matters, personal growth and learning, caring for yourself and family, being your true self, career development in an international company, and is recognized as a great place to work, one of the most admired companies, and best for diversity, working mothers, female executives, and scientists.

What makes a strong candidate for this Regulatory Affairs Specialist II role?

Strong candidates will have experience authoring and submitting international regulatory submissions, preparing regulatory applications, and partnering across business functions in a consultative role for product registrations worldwide.

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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