Posted: 12 March
Offer description
Job Description
The Regulatory Affairs Specialist supports the administration and development of EU Authorised Representative (AR) and UK Responsible Person (RP) activities within the Abbott Rapid Diagnostics division according to appropriate procedures and processes.
* 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.
* Supports 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;
* Updates company and external databases with required information and statuses for licenses, registrations, renewals, products, and other required data, i.e. EUDAMED etc.
* Exhibits professional behaviour with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
* Maintains awareness of the quality consequences which may occur from the improper performance of their specific job.
* Performs other duties and projects as assigned.
* Acts as an initial and ongoing point of contact for customer sites and external regulators and others for AR and UK RP related requests.
* Collates electronic and paper documents to allow the registration or removal of products according to procedures
* Reviews external databases and updates external databases to ensure that information related to products and manufacturers is correctly assigned.
* Administers and delivers requests for documents such as Certificates of Free Sale from Competent Authorities as required
* Reviews and administers documents related to all types of regulatory, AR and UK RP activities.
* Communicates any complaints or potential complaints to the PRRC, Customer site and Abbott complaint handling systems as required
* Follows Abbott policies, procedures and methodologies.
* Processes Purchase Order Requisition numbers and submits invoices to Accounts Payable as required.
Education and 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 organisational skills.
* Multitasking and time-management skills, with the ability to prioritise tasks.
