JOB DESCRIPTION:

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.

Regulatory Strategy & Compliance

• 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.

Cross-Functional Leadership & Collaboration

• 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.

Risk Management

• 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, Smart Sheet, PowerBi, PowerPoint, Excel and Word.

• Good interpersonal and presentation skills are required in leading crossfunctional 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

The base pay for this position is

N/A
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Project Management

DIVISION:

CMI ARDx Cardiometabolic and Informatics:

LOCATION:

United Kingdom > Dundee : 17 Luna Place

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable