Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutrition, and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Overview

For the Abbott Rapid Diagnostics Infectious Disease - Emerging Markets Business Unit, we are looking for a talented and dynamic Regulatory professional to coordinate and manage all related RA activities for the Abbott portfolio in Malaysia as part of the APAC RA regional team.

Responsibilities

• Support and develop regulatory submission plan for Malaysia in collaboration with regional RA, project team, manufacturing sites, supply chain, marketing, country manager.
• Shape and support innovative regulatory strategy for new product introduction, pre-market registrations, and execute change notification amendment registrations to support product life cycle management as per business needs.
• 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;
• Report submission status via defined Key Performance Indicators;
• Represents RA and/or APAC at relevant meetings.
• Responsible for the review of promotional material for Malaysia.
• Support the 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.

Skill, Education, Experience

• BSc or equivalent.
• A minimum of 5 years experience in Regulatory Affairs in Medical Devices, ideally in IVDs

• Demonstrated working knowledge of the medical diagnostics industry, including Software as a Medical Device (SaMD).
• They have demonstrated capacity in project management.
• Able to navigate in a cross-functional environment.
• Knows the Malaysia IVD medical device regulations, ASEAN Medical Device Directive, US FDA, EU IVDD/IVDR regulatory environment, legislation, industry standards, and guidance and digital health product regulations and requirements.
• Strong knowledge of ISO 13485 and GDPMD requirements.
• Excellent written and oral communication skills in English
• Attention to detail.
• Strong interpersonal skills.
• Possess the highest levels of integrity and diplomacy.
• Capacity to maintain the highest levels of confidentiality internally and externally.