Job Description

JOB DESCRIPTION:PLEASE NOTE THIS IS A 1- Year FTCAbout AbbottAbbott 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, nutritional's and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.OverviewFor the Abbott Rapid Diagnostics Infectious Disease 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 a designated list of countries as part of the APAC RA regional team.Responsibilities

• Support and develop regulatory submission plan for the region in terms of IVDR transition project in collaboration with Global RA IVDR project team, Legal manufacturing sites, supply chain, marketing, commercial and Distributor countries;
• Assist to manage applicable change control projects for regional team by working closely with relevant manufacturing sites and other functions to obtain all necessary dossiers to support product registration, or amendment to existing product certificates and maintain database with risk escalation if necessary.
• Report submission status (IVDR, Change Control) via defined Key Performance Indicators into necessary database;
• Secondary support as backup towards local Regulatory Affairs matters as applicable.
• Track applicable regulatory milestones in internal Regulatory database;
• Represents RA and/or APAC at relevant meetings such as IVDR meetings or change control meetings;
• 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.
• Ad hoc duties as deemed necessary for the position and business

Qualifications

• BSc or equivalent.
• A minimum of 2 years experience in Regulatory Affairs in Medical Devices, ideally in IVDs

Competencies and Attributes

• Demonstrable working knowledge of the medical diagnostics industry in the regions they will support
• Demonstrated capacity in project management
• Able to navigate in a cross functional environment
• Knowledge of the regulatory environment(local MOH regulations), legislation, industry standards and guidance
• Excellent written and oral communication skills in English
• Attention to detail.
• Strong interpersonal skills.
• Highest levels of integrity and diplomacy.
• Capacity to maintain the highest levels of confidentiality internally and externally.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: Regulatory OperationsDIVISION: ID Infectious DiseaseLOCATION: South Africa
Johannesburg : Woodlands Office ParkADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: NoMEDICAL SURVEILLANCE: NoSIGNIFICANT WORK ACTIVITIES: Not Applicable

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