Description

<h2>JOB DESCRIPTION:</h2>MAIN PURPOSE OF JOB<ul><li>This is a leadership role with expectations aligned to the Leadership Capabilities and Behaviours as set out in the Abbott UK Employee Handbook.</li><li>To define, plan, coordinate and integrate regulatory activities associated with systems, processes and materials across Dundee, Oslo and San Diego.</li><li>Document and maintain all project related plans, schedules, budgets (where applicable), meeting minutes, management reviews, etc.</li><li>Track and report project status and progress to Management. Functionally manage individuals in order to deliver projects and / or deliverables.</li><li>Functional management for individuals supporting own projects or running projects of their own.</li><li>Support the day-to-day running of the Regulatory Affairs Department along with RA manager to promote a commercially aware, pro-active compliance culture</li><li>Lead, sponsor and support as needed to ensure that the business complies with current standards, regulations and industry expectations.</li></ul>ACCOUNTABILITIES Project & Program Management<ul><li>Manage projects and deliverables within agreed constraints of time, cost and quality.</li><li>Devise scope, schedules, resources, and costs for regulatory projects.</li><li>Track and deliver projects according to agreed schedules, scope, and budget.</li><li>Document and maintain all project-related plans, schedules, meeting minutes, management reviews, etc.</li><li>Track and report project status and progress to management in an effective and efficient manner; adapt presentation style to different audiences.</li><li>Facilitate discussions on challenging project topics to gain consensus or remove roadblocks.</li><li>Encourage and promote a “lessons learned” culture.</li><li>Represent the interests of the department within the business.</li><li>Perform other duties as assigned by line or department management.</li></ul>Regulatory Strategy & Compliance<ul><li>Monitor regulatory changes and communicate potential impact to internal stakeholders.</li><li>Ensure ongoing compliance across product lines and processes.</li><li>Provide regulatory guidance across the product lifecycle, including development, submissions, audits, and post-market activities.</li><li>Prepare, submit, or oversee regulatory submissions (e.g., renewals, new registrations) throughout product development and lifecycle management.</li><li>Lead efforts to harmonize and streamline regulatory procedures across CMI manufacturing sites.</li><li>Ensure site-specific regulatory support is aligned and cascaded appropriately to team members, promoting traceability and delivery success.</li><li>Champion RA projects (as delegated) and report on regulatory performance, compliance, and required improvements.</li><li>Report on regulatory metrics.</li><li>Know and apply health and safety procedures as well as relevant corporate and divisional policies.</li><li>Be aware of and apply policies from the Abbott UK Employee Handbook.</li></ul> Cross-Functional Leadership & Collaboration<ul><li>Lead and participate in cross-functional project teams involved in business-critical initiatives (e.g., new product introduction, development projects, major design changes).</li><li>Serve as a liaison between regulatory, manufacturing, quality, operations, labelling, and other internal stakeholders to ensure alignment and execution of regulatory plans.</li><li>Communicate effectively and build strong relationships with internal functions, management, external suppliers, and regulatory bodies.</li><li>Work collaboratively with the broader business unit to implement best practices and deliver key corporate objectives.</li></ul> Risk Management<ul><li>Identify potential project and regulatory risks.</li><li>Manage risks through mitigation strategies, alternative approaches or acceptance of risk</li></ul>BASE REQUIREMENTS<ul><li>Degree or equivalent, preferably a life science subject area</li><li>Experience in a regulated industry preferred</li></ul>BACKGROUND<ul><li>Can demonstrate a history of managing projects and delivering successfully.</li><li>Knowledge of Project Management tools such as MS Project, SmartSheet, PowerBi, PowerPoint, Excel and Word.</li><li>Good interpersonal and presentation skills are required in leading crossfunctional team and communicating project status.</li><li>Experience in product development or manufacturing in a medical device product.</li><li>This position requires the ability to collect information from multiple sources, sort through, integrate, and resolve often conflicting requirements, and drive an organization through the various issues to result in a successful product launch.</li><li>Understanding of global IVD Regulations</li></ul>     The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted. <h2>JOB FAMILY:</h2>Project Management     <h2>DIVISION:</h2>CMI ARDx Cardiometabolic and Informatics        <h2>LOCATION:</h2>United Kingdom > Dundee : 17 Luna Place     <h2>ADDITIONAL LOCATIONS:</h2>Norway > Oslo : Kjelsasveien 161     <h2>WORK SHIFT:</h2>Standard     <h2>TRAVEL:</h2>Not specified     <h2>MEDICAL SURVEILLANCE:</h2>Not Applicable     <h2>SIGNIFICANT WORK ACTIVITIES:</h2>Not Applicable

Senior Specialist Regulatory Affairs

Description

Abbott

Pipeline