Job Description
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, nutritionals and branded generic medicines.
Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 5,000 people across nine sites.
Abbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for the treatment and management of diseases and other conditions.
The Regulatory Affairs Specialist supports the administration and development of the EU Authorised Representative (AR) and UK Responsible Person (RP) activities within the Abbott Rapid Diagnostics division according to appropriate procedures and processes.
The Regulatory Affairs Specialist will be responsible for:
- Carrying out duties in compliance with established business policies and procedures.
- Demonstrating commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, MHRA, HPRA and other regulatory agencies.
- Supporting the assessment of the regulatory status of products with regards to applicable regulations, including EU MDR / IVDR and UK and Switzerland MD and IVD regulations.
- Preparing for and assisting with quality audits - internal and external, as required.
- Updating company and external databases with required information and statuses for licenses, registrations, renewals, products, and other required data.
- Exhibiting professional behaviour with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Understanding and maintaining awareness of the quality consequences which may occur from the improper performance of their specific job.
- Performing other duties and projects as assigned.
- Acting as an initial and ongoing point of contact for customer sites and external regulators and others for AR and UK RP related requests.
- Collating electronic and paper documents to allow the registration or removal of products according to procedures.
- Reviewing external databases and updating external databases to ensure that information related to products and manufacturers is correctly assigned.
- Administering and delivering requests for documents such as Certificates of Free Sale from Competent Authorities as required.
- Forwarding documents from the manufacture, AR, UK RP or Competent Authority, as required.
- Appropriately reviewing and administering documents related to all types of regulatory, AR and UK RP activities.
- Communicating any complaints or potential complaints to the PRRC, Customer site and Abbott complaint handling systems as required.
- Following Abbott policies, procedures and methodologies.
- Processing Purchase Order Requisition numbers and submitting invoices to Accounts Payable as required.
- Completing any other duties as may be assigned by the PRRC or line manager.
The ideal candidate will have:
- Fluent business English skills with good interpersonal, excellent communication and presentation skills.
- Experience of AR activities previously is desirable but not essential.
- Experience in medical devices or IVD regulation or regulatory activities is desirable but not essential.
- Bachelor's Degree in a related field is required.
- High Proficiency in MS Office software.
- Flexibility to travel as required.
- Excellent administrative, organisational and business support skills, with the ability to multi-task and to work calmly under pressure.
- Excellent communication skills (written & verbal across cultures).
- Ability to coordinate meetings (by phone, video conference and face to face) to drive results and build relationships.
- Demonstrated administrative, written and verbal communication, negotiation and influencing skills.
- A track record of supporting multifunctional teams.
- Organised, detail oriented, have a high level of confidentiality, and ability to work under pressure with changing priorities and deadlines.
- Ability to be resourceful and proactive when issues arise.
- Excellent organisational skills.
- Multitasking and time-management skills, with the ability to prioritise tasks.