Administration / Office Support JobsAR Regulatory Administrator

  • GY51681
  • Permanent
  • Galway, Mayo

Collins McNicholas

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

 

Requirements

  • 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.

 

Personal Characteristics

  • 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.

deirdre.moran@collinsmcnicholas.ie

(091) 706710

 

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