I am partnering with Abbott Rapid Diagnosticsto hire a Regulatory Affairs Specialist IIon an initial on 12 month contract tosupport an exciting new project.
Working Model: Remote Overview For 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 EU RA regional team.
Responsibilites 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 in country Distributors.
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.
Track applicable regulatory milestones in internal Regulatory database per defined Key Performance Indicators.
Represent RA and/or region at relevant meetings such as IVDR meetings or change control meetings.
Provide secondary support as backup towards local Regulatory Affairs matters as applicable.
Support Abbott strategic Quality and Regulatory Affairs Goals and objectives.
Monitor developing regulations and gather regulatory intelligence that may be relevant to the business.
Perform ad hoc duties as deemed necessary for the position and business.
Qualifications BSc or equivalent.
A minimum of 2 years experience in Regulatory Affairs, preferably in Medical Devices, ideally in IVDs.
Competencies and Attributes Demonstrable working knowledge of the pharmaceutical industry in the regions they will support.
Demonstrated capacity in project management.
Ability to navigate in a cross-functional environment.
Knowledge of the regulatory environment in European Union (MDR/IVDR, local 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.
?For a confidential discussion and more information on the role, please contact Emma Daly Skills: IVDR Regulatory Affairs Project Management Benefits: Work From Home