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

Alameda, California, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ 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 processes and tools
Knowledge of developing, maintaining, and ensuring compliance with Corporate and Divisional policies/procedures
Experience providing regulatory input to product lifecycle planning and project strategy based on regulatory changes
Ability to monitor emerging regulatory issues, evaluate product issues, and develop compliant solutions
Experience acting as a liaison with departments like Quality, R&D, Legal, Operations, Marketing, and Clinical Affairs
Proven ability to hire, retain, develop diverse high-qualified staff, and provide performance feedback
On-site work availability 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/maintaining product registration/approval and compliant release
Drive strategic engagement with regulatory authorities during development and review to secure approvals
Coordinate with cross-functional teams to meet all internal/external requirements prior to product release
Manage multiple programs independently, identifying risk areas and escalating issues
Own the product release process, developing/refining processes and tools for efficiency and control
Develop, maintain, and ensure compliance with applicable Corporate and Divisional policies/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 liaison with other departments (e.g., Quality, R&D, Legal, Operations, Marketing, Clinical Affairs) for major initiatives
Hire, retain, and develop diverse, highly qualified staff and provide ongoing performance feedback
Maintain a safe work environment

Skills

Key technologies and capabilities for this role

Regulatory AffairsRegulatory StrategyMedical DevicesProduct RegistrationAPAC RegulationsStrategic PlanningDiabetes Care

Questions & Answers

Common questions about this position

What benefits does Abbott offer?

Abbott provides career development opportunities, free medical coverage through the Health Investment Plan (HIP) PPO, an excellent retirement savings plan with high employer contribution, tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit.

Is this position remote or on-site?

This is an on-site position at the Alameda, CA location.

What are the main responsibilities of this role?

The role involves leading strategic planning for regulatory registration in APAC, overseeing processes for product approval and release, engaging with regulatory authorities, and coordinating with cross-functional teams.

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, 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 regulatory affairs for APAC markets, experience leading strategic planning and processes for product registration, skills in engaging regulatory authorities on complex technical issues, and ability to coordinate with cross-functional global 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.

Land your dream remote job 3x faster with AI

Try Jobo Free