SEA Head of Regulatory Affairs at Abbott

Singapore

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Diagnostics, Medical DevicesIndustries

Requirements

Bachelor or higher degree in Biomedical/Medical Sciences, Pharmacy, Engineering or other Life Sciences
A minimum of 7 years’ experience in Regulatory Affairs in Medical Devices, preferably in IVDs
Demonstrable working knowledge of the medical diagnostics industry, including Software as a Medical Device (SaMD)
Demonstrated capacity in project management
Able to navigate in a cross functional environment
Knowledge of the APAC regulatory environment (ASEAN, SAARC countries), including SaMD, US FDA, AMDD, IVDR (EU 2017/746), IMDRF and regional digital health regulations and requirements, legislation, industry standards and guidance
Excellent written and oral communication skills in English and an ability to influence, lead, negotiate and work effectively at all levels
Attention to detail
Strong interpersonal skills
Highest levels of integrity and diplomacy

Responsibilities

Drive, develop and support regulatory submission plans for the region in collaboration with project team, manufacturing sites, supply chain, marketing, country manager and distributor countries
Responsible for RA functional report for Southeast Asia countries
Manage the team to ensure timely submission and approval of quality best in class regulatory documentation for pre-market registrations, change notification, or renewal registrations to support product life cycle management as per business needs
Lead the development and execution of innovative regulatory strategy for New Product Introduction (NPI) in the region; analyze and identify regulatory requirements against project needs
Lead, manage and track execution of major regulatory transition in the region to ensure compliance and maintain commercial availability i.e. EU IVDR
Work closely with relevant manufacturing sites and other functions to obtain all the necessary documents to support product registration, renewal, or amendment to existing product certificates
Ensure timely execution of regulatory strategies as per plan
Track regulatory milestones in internal Regulatory database
Develop, manage, and report regional metrics to track and define Key Performance Indicators for SEA countries
Represents RA and/or APAC at relevant meetings
Responsible for review of promotional material for assigned geography location
Support Abbott strategic Quality and Regulatory Affairs Goals and objectives
Monitor developing regulations and gather regulatory intelligence that may be relevant to the business. Conduct impact assessment and disseminate as appropriate to key stakeholders
Develop and maintain positive relationship with all stakeholders either internal or external including key opinion leaders and key influencers in regulatory bodies & industry associations while building Abbott Rapid Diagnostics credibility and trust
Attract, develop and retain a high performing regulatory organization while developing a strong talent and leadership pipeline capable of delivering regulatory success in a changing market environment

Skills

Key technologies and capabilities for this role

Regulatory AffairsRegulatory SubmissionsProduct RegistrationRenewal RegistrationsChange NotificationNPIEU IVDRRegulatory StrategyComplianceTeam ManagementProject Management

Questions & Answers

Common questions about this position

What countries does this role cover in Southeast Asia?

The role covers Southeast Asia countries including Thailand, Malaysia, Philippines, Singapore, Indonesia, Vietnam, Cambodia, Laos & Myanmar.

What are the main responsibilities of the Head of Regulatory Affairs position?

Responsibilities include driving regulatory submission plans, managing the RA team for timely submissions and approvals, leading innovative strategies for new product introductions, tracking regulatory transitions like EU IVDR, and developing relationships with stakeholders.

Is there a team management component to this role?

Yes, the role involves managing the RA functional report for Southeast Asia countries and attracting, developing, and retaining a high-performing regulatory organization.

What salary or compensation is offered for this position?

This information is not specified in the job description.

What kind of experience makes a strong candidate for this role?

A strong candidate is a talented and dynamic regulatory professional with leadership experience in managing RA activities, developing regulatory strategies, team management, and building relationships with regulatory bodies and stakeholders.

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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