Regulatory Affairs Specialist The Regulatory Affairs Specialist supports the administration and development of the EU Authorised Representative (AR) and UK Responsible Person (RP) activities within the Rapid Diagnostics division according to appropriate procedures and processes.
You will support 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 Management System. You shall support the nominated UK Responsible Person(s) to ensure that appropriate oversight of activities is maintained and any updates undertaken.
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 to the PRRC, Customer site and company 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.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.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 is 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.
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