Contract ( FTC) - RA Specialist at Abbott

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 1 years’ experience in Regulatory Affairs in Medical Devices, ideally in IVDs