A global healthcare leader in Galway is seeking to hire a Regulatory Affairs Specialist.
MAJOR RESPONSIBILITIES:
* Carries out duties in compliance with established business policies and procedures.
* Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, MHRA, HPRA and other regulatory agencies.
* Support 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
* Prepares for and assists with quality audits - internal and external, as required;
* Update company and external databases with required information and statuses for licenses, registrations, renewals, products, and other required data, i.e. EUDAMED etc.
* Responsible for 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.
* Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
* Perform other duties and projects as assigned.
* Act as an initial and ongoing point of contact for customer sites and external regulators and others for AR and UK RP 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 Competent Authorities as required
* Forward documents from the manufacture, AR, UK RP or Competent Authority, as required.
* Appropriate review and administration of documents related to all types of regulatory, AR and UK RP activities.
* Communicate any complaints or potential complaints
* 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
EDUCATION & COMPETENCIES:
* Fluent business English speaker 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 is desirable but not essential.
* High Proficiency in MS Office software.
* 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.