Regulatory Affairs Manager – Diabetes Care (on-site) at Abbott

Alameda, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Work on-site out of Alameda, CA location in the Diabetes Care Division
Experience in US submissions, including Premarket and Postmarket submissions for continuous glucose monitoring systems
Working knowledge of insulin and drug solutions for diabetes management or past experience in submitting NDA/BLA submissions (preferred)
Department level influence with experience in US submissions and on-market changes
Generally recognized as an expert resource both within Abbott and externally
Ability to monitor and influence changing regulations and guidance
Ability to interface with outside regulatory agencies and trade associations
Ability to develop innovative regulatory submission strategy
Ability to provide executive management with regulatory metrics/information

Responsibilities

Develop global regulatory strategies for product development and planning throughout the product lifecycle
Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions
Provide technical leadership and strategic input on complex issues and to business units
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
Create project plans and timelines
Lead functional groups in the development of relevant data to complete a regulatory submission
Write and edit technical documents
Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions
Negotiate with regulatory authorities

Skills

Key technologies and capabilities for this role

Regulatory AffairsDiabetes CareMedical DevicesHealthcare ComplianceRA ManagementGlucose MonitoringSensing Technology

Questions & Answers

Common questions about this position

Is this role remote or on-site?

This is an on-site position based out of the Alameda, CA location in the Diabetes Care Division.

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.

What skills and experience are required for this Regulatory Affairs Manager role?

The role requires experience in US submissions including Premarket and Postmarket submissions for continuous glucose monitoring systems, department level influence as an individual contributor, and recognition as an expert resource. Preferred experience includes working knowledge of insulin and drug solutions for diabetes management or submitting NDA/BLA submissions, plus ability to monitor and influence changing regulations.

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, and living a full life. It is recognized as a great place to work, one of the most admired companies by Fortune, and best for diversity, working mothers, female executives, and scientists.

What makes a strong candidate for this position?

Strong candidates will have experience in US regulatory submissions for medical devices like continuous glucose monitors, expertise in Premarket and Postmarket activities, department-level influence, and preferably knowledge of diabetes drug solutions or NDA/BLA submissions.

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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