Regulatory Affairs Manager – APAC - 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

Bachelor's Degree or an equivalent combination of education and experience
4-5 years’ experience in a regulated industry (e.g., medical products, nutritionals)
2-5 years of experience in regulatory pr

Responsibilities

Manage a team of regulatory specialists
Develop and advance the organization's policy and procedures for regulatory affairs and compliance to establish a compliant culture
Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on regulatory requirements in the APAC region for Diabetes Care’s projects
Utilize technical regulatory skills to propose strategies on complex issues
Work closely with in-country regulatory representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the APAC region
Provide strategic input and technical guidance on regulatory authority queries
Evaluate proposed design and manufacturing changes for regulatory impact and implement required regulatory actions
Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle
Oversee processes involved with maintaining annual licenses, registrations, listings, and patent information
Ensure compliance with product post-marketing approval requirements
Review product labeling and promotional materials to ensure compliance with relevant regulatory requirements
Provide regulatory support for internal and external audits
Manage a small team overseeing the Diabetes Care product portfolio in the APAC region
Create robust global regulatory strategies
Work with cross-functional teams as the regulatory SME
Provide support for compiling regulatory submissions
Ensure data is effectively presented for the registration of products in the APAC region

Skills

Key technologies and capabilities for this role

Regulatory AffairsAPAC RegulationsMedical DevicesDiabetes CareComplianceGlucose MonitoringRegulatory Compliance

Questions & Answers

Common questions about this position

Is this role remote or on-site?

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

What benefits does Abbott offer?

Benefits include 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 are the main responsibilities of this role?

Responsibilities include managing a team of regulatory specialists, developing policies and procedures for regulatory affairs and compliance, representing Regulatory Affairs on cross-functional teams, providing strategic input on APAC regulatory requirements, and utilizing technical skills for complex issues.

What is the salary for this position?

This information is not specified in the job description.

Does this role involve managing a team?

Yes, you will be responsible for managing a small team of regulatory specialists overseeing the Diabetes Care product portfolio in the APAC region.

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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