An exciting opportunity for an Authorised Representative Regulatory Administrator to work for a leading Multinational company in Galway.
Responsibilities and Duties
- Act as an initial and ongoing point of contact for customer sites and external regulators and others for AR related requests.
- Collation of electronic and paper documents to allow the registration or removal of products according to procedures
- Review of external databases and update of external databases to ensure that information related to products and manufacturers is correctly assigned.
- Administer and deliver requests for documents such as Certificates of Free Sale from external Competent Authorities as required
- Forward documents from the manufacture, AR or Competent Authority as required.
- Appropriate administration of documents related to all type of AR activities.
- Communicate any complaints or potential complaints to the PRRC, Customer site and Abbott complaint handling systems as required
- Follow ABBOTT policies, procedures and methodologies.
- Process Purchase Order Requisition numbers and submit invoices to Accounts Payable as required.
- Complete any other duties as may be assigned by the PRRC or line manager
- 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 is desirable but not essential.
- High Proficiency in MS Office Products.
- Flexibility to travel as required.
- In order to interact with sites on different time zones occasional out of hours working 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 organizational skills.
- Multitasking and time-management skills, with the ability to prioritize tasks.
- A confident engaging personality who can co-ordinate the activities in a professional and efficient manner. Must have the strength of character to push back at times and diplomatically insist that deadlines and standards are met.
- Must be a good communicator and able to present a professional image of the business to a variety of internal and external visitors at all times.
- Will have tact and sensitivity and be able react accordingly to situations.
- Will be an expert on use of all office tools and be able to quickly learn and apply new applications.
- Will be able to command the respect and trust of the broader organisation.
- Volunteers readily and completes tasks on time.
- Follows organizational direction and responds to management direction.
- Ability to work in a fast paced, complex, ambiguous and matrix organization.
For a confidential discussion and more information on the role, please contact Deirdre Moran.