Senior Specialist Regulatory Affairs in Dundee

MAIN PURPOSE OF JOB

This is a leadership role with expectations aligned to the Leadership Capabilities and Behaviours as set out in the Abbott UK Employee Handbook. To define, plan, coordinate and integrate regulatory activities associated with systems, processes and materials across Dundee, Oslo and San Diego. Document and maintain all project related plans, schedules, budgets (where applicable), meeting minutes, management reviews, etc. Track and report project status and progress to Management. Functionally manage individuals in order to deliver projects and/or deliverables. Functional management for individuals supporting own projects or running projects of their own. Support the day-to-day running of the Regulatory Affairs Department along with RA manager to promote a commercially aware, pro-active compliance culture. Lead, sponsor and support as needed to ensure that the business complies with current standards, regulations and industry expectations.

ACCOUNTABILITIES:

• Project & Program Management

• Manage projects and deliverables within agreed constraints of time, cost and quality.
• Devise scope, schedules, resources, and costs for regulatory projects.
• Track and deliver projects according to agreed schedules, scope, and budget.
• Document and maintain all project-related plans, schedules, meeting minutes, management reviews, etc.
• Track and report project status and progress to management in an effective and efficient manner; adapt presentation style to different audiences.
• Facilitate discussions on challenging project topics to gain consensus or remove roadblocks.
• Encourage and promote a "lessons learned" culture.
• Represent the interests of the department within the business.
• Perform other duties as assigned by line or department management.

• Monitor regulatory changes and communicate potential impact to internal stakeholders.
• Ensure ongoing compliance across product lines and processes.
• Provide regulatory guidance across the product lifecycle, including development, submissions, audits, and post-market activities.
• Prepare, submit, or oversee regulatory submissions (e.g., renewals, new registrations) throughout product development and lifecycle management.
• Lead efforts to harmonize and streamline regulatory procedures across CMI manufacturing sites.
• Ensure site-specific regulatory support is aligned and cascaded appropriately to team members, promoting traceability and delivery success.
• Champion RA projects (as delegated) and report on regulatory performance, compliance, and required improvements.
• Report on regulatory metrics.
• Know and apply health and safety procedures as well as relevant corporate and divisional policies.
• Be aware of and apply policies from the Abbott UK Employee Handbook.

• Lead and participate in cross-functional project teams involved in business-critical initiatives (e.g., new product introduction, development projects, major design changes).
• Serve as a liaison between regulatory, manufacturing, quality, operations, labelling, and other internal stakeholders to ensure alignment and execution of regulatory plans.
• Communicate effectively and build strong relationships with internal functions, management, external suppliers, and regulatory bodies.
• Work collaboratively with the broader business unit to implement best practices and deliver key corporate objectives.

• Identify potential project and regulatory risks.
• Manage risks through mitigation strategies, alternative approaches or acceptance of risk.

BASE REQUIREMENTS

• Degree or equivalent, preferably a life science subject area.
• Experience in a regulated industry preferred.

BACKGROUND

• Can demonstrate a history of managing projects and delivering successfully.
• Knowledge of Project Management tools such as MS Project, SmartSheet, PowerBi, PowerPoint, Excel and Word.
• Good interpersonal and presentation skills are required in leading cross-functional team and communicating project status.
• Experience in product development or manufacturing in a medical device product.
• 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.
• Understanding of global IVD Regulations.