You will be responsible for a portfolio of cutting-edge medical devices & IVDs, leading regulatory activities for new product introductions and significant on-market changes for the Europe, Middle East and Africa (EMEA) region. You will work as part of a global team, to develop, lead and implement strategies that will ensure the timely introduction of new products onto the international market in a fast-paced environment. You will coordinate and oversee preparation of complete and scientifically sound regulatory submissions and lead interactions with the Notified Body and country regulatory contacts to resolve issues arising during the regulatory submission review process to ensure a timely approval process. Core Job Responsibilities
Formulate, develop and lead business critical regulatory strategies for the EMEA region. Act as the regulatory subject matter expert in design control projects, assessing changes and managing roll out programs for existing products and new launches. Become a technical expert in ADC devices and lead interactions with EU Notified Body. Manage the creation and development of EU & UK Technical files in accordance with MDR 2017/745 & IVDR 2017/746. Provide coaching and mentoring to more junior team members, with the possibility of management responsibilities for a small team. Identify and implement process improvements and efficiencies per the global regulatory affairs strategy. In addition to a competitive salary, Abbott offers a highly attractive benefits package which includes a defined-contribution pension scheme, a share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme which you can tailor to your own requirements.
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