Our client a medical device company in Galway is looking to hire a Regulatory Administrator - Authorised Representative for their site.
The Authorised Representative (AR) Regulatory Administrator supports the administration and development of AR activities according to appropriate procedures and processes. The AR Regulatory Administrator also supports the nominated Person Responsible for Regulatory Compliance (PRRC) to ensure that appropriate oversight of activities is maintained and any updates required are actioned through the RDIL Quality System.
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 company 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.
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.