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

Knowledge of regulatory history, guidelines, policies, standards, practices, requirements and precedents
Knowledge of regulatory agency structure, processes and key personnel
Knowledge of principles and requirements of applicable product laws
Knowledge of principles and requirements of promotion, advertising and labeling
Ability to interpret and apply regulatory requirements
Knowledge of domestic and international regulatory guidelines, policies and regulations
Knowledge of ethical guidelines of the regulatory profession, clinical research and regulatory process
Ability to communicate effectively verbally and in writing
Ability to write and edit technical documents
Ability to communicate and work with people from various disciplines and cultures
Ability to negotiate internally and externally with regulatory agencies
Ability to plan and conduct meetings and work with cross-functional teams
Ability to clearly explain and articulate regulatory plans to senior leaders
Ability to define regulatory strategy
Ability to perform risk assessment or analysis
Ability to juggle multiple and competing priorities
Analytical thinking with good problem-solving skills
Ability to organize and track complex information
Ability to exercise judgment within broadly defined practices and policies
Broad knowledge of various technical alternatives and their potential impact on the business
In-depth knowledge of business functions and cross-group dependencies/relationships
Ability to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues
Department/group/site level influence as an expert resource

Responsibilities

Combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation
Anticipate regulatory obstacles and emerging issues
Lead functional groups to complete a regulatory submission
Share knowledge and expertise with others in support of team activities
Identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide
Compile, prepare, review and submit regulatory submissions to authorities
Lead functional groups in the development of relevant data to complete a regulatory submission
Influence others

Skills

Key technologies and capabilities for this role

Regulatory AffairsRegulatory ComplianceMedical DevicesHealthcare RegulationsScientific KnowledgeBusiness RegulationsProduct LegislationLegislation Compliance

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.

Is this role remote or on-site?

The role is on-site in Pleasanton, CA.

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

Required skills include regulatory knowledge such as anticipating obstacles, leading submissions, and interpreting requirements; strong communication skills for writing technical documents and working across disciplines; and understanding of regulatory agency processes, product laws, and ethical guidelines.

What is the company culture like at Abbott?

Abbott emphasizes doing work that matters, personal growth, caring for yourself and family, being your true self, career development, and is recognized as a great place to work for diversity, working mothers, female executives, and scientists.

What makes a strong candidate for this position?

A strong candidate combines knowledge of scientific, regulatory, and business issues, acts as an expert resource with department influence, leads regulatory submissions, and excels in communication across disciplines.

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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