Regulatory Affairs Manager – Heart Failure (on-site) at Abbott

Pleasanton, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Strong understanding of scientific, regulatory, and business issues
Knowledge of domestic and international regulatory guidelines, policies, and regulations
Familiarity with regulatory agency structure, processes, and key personnel
Ability to anticipate regulatory obstacles and emerging issues
Excellent written and verbal communication skills
Ability to communicate effectively with diverse teams and cultures

Responsibilities

Lead functional groups to complete regulatory submissions
Compile, prepare, review, and submit regulatory submissions to authorities
Interpret and apply regulatory requirements
Identify data needed for regulatory submissions
Ensure products meet required legislation
Maintain knowledge of ethical guidelines of the regulatory profession, clinical research, and regulatory process

Skills

Key technologies and capabilities for this role

Regulatory SubmissionsGlobal RegulationsRegulatory GuidelinesProduct RegistrationRegulatory Agency ProcessesScientific KnowledgeBusiness AcumenWritten CommunicationVerbal CommunicationTeam Leadership

Questions & Answers

Common questions about this position

Is this position remote or on-site?

This is an on-site position located in Pleasanton, CA.

What benefits does Abbott offer?

Abbott provides career development opportunities, access to free medical coverage (HIP PPO) in the next calendar year, an excellent retirement savings plan with high employer contribution, tuition reimbursement, Freedom 2 Save student debt program, FreeU education benefit, and recognition as a great place to work.

What key skills are required for the Regulatory Affairs Manager role?

Required skills include a strong understanding of scientific, regulatory, and business issues; knowledge of domestic and international regulatory guidelines; familiarity with regulatory agency structure and processes; ability to anticipate regulatory obstacles; and excellent written and verbal communication skills.

What is Abbott's company culture like?

Abbott is recognized as a great place to work, one of the most admired companies, and one of the best big companies for diversity, working mothers, female executives, and scientists, with a global presence employing 114,000 colleagues.

What makes a strong candidate for this role?

A strong candidate will have expertise in regulatory affairs, including knowledge of global regulations, the ability to lead submissions and anticipate obstacles, and excellent communication skills for working with diverse teams.

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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