Principal Regulatory Affairs Specialist – APAC - Diabetes Care (on-site) at Abbott

Alameda, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Expertise in leading strategic planning for regulatory affairs in APAC markets, particularly for diabetes care products
Ability to develop and deploy innovative solutions for timely regulatory registration and product release
Strong experience overseeing processes and team efforts for product registration, approval, and compliant release
Proficiency in driving strategic engagement with regulatory authorities, communicating complex technical concepts
Skill in coordinating with cross-functional teams (e.g., global Regulatory Affairs, Commercial, Marketing, Supply Planning, Customer Service, Quality, R&D, Operations)
Capability to manage multiple programs independently, identify risks, and escalate issues
Ownership of product release processes, including developing and refining tools for efficiency and control
Knowledge of developing, maintaining, and ensuring compliance with Corporate and Divisional policies
Experience providing regulatory input to product lifecycle planning and project strategy based on regulatory changes
Ability to monitor emerging regulatory issues and guide responses
Expertise in evaluating product issues and developing compliant solutions for specific geographies
Experience acting as a liaison with departments like Quality, R&D, Legal, Operations, Marketing, and Clinical Affairs
Proven ability to hire, retain, develop diverse staff, and provide performance feedback
Willingness to work on-site at Alameda, CA location

Responsibilities

Execute and ensure timely product registration and release for distribution in APAC geographies
Oversee and optimize processes and team efforts for obtaining and maintaining product registration/approval
Drive strategic engagement with regulatory authorities during development and review to secure approvals
Coordinate with cross-functional teams to meet all internal and external requirements prior to product release
Manage multiple programs independently, identifying risk areas and escalating issues
Own the product release process, developing and refining processes and tools for efficiency and control
Develop, maintain, and ensure compliance with applicable Corporate and Divisional policies and procedures
Provide regulatory input to product lifecycle planning and project strategy based on regulatory changes
Monitor emerging regulatory issues and guide team responses
Evaluate product issues and develop informed, compliant solutions aligned with geography-specific requirements
Act as a liaison with other departments (e.g., Quality, R&D, Legal, Operations, Marketing, Clinical Affairs) for major initiatives
Hire, retain, and develop a diverse, highly qualified staff and provide ongoing performance feedback
Maintain a safe work environment

Skills

Key technologies and capabilities for this role

Regulatory AffairsStrategic PlanningRegulatory RegistrationProduct ReleaseMedical DevicesDiabetes CareAPAC Regulations

Questions & Answers

Common questions about this position

What benefits does Abbott offer?

Abbott provides free medical coverage through 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?

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

What are the main responsibilities of this role?

The role involves executing timely product registration and release for APAC markets, leading regulatory affairs processes, driving strategic engagement with regulatory authorities, and coordinating with cross-functional teams like global Regulatory Affairs, Commercial, Quality, R&D, and Operations.

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 Principal Regulatory Affairs Specialist role?

Strong candidates will have expertise in leading strategic regulatory planning, engaging with APAC regulatory authorities, optimizing registration processes, and coordinating across global and cross-functional teams in the diabetes care sector.

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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