Senior Specialist Regulatory Affairs

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• 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.
  

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• 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.
  

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• 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 harmonise 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.
  

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• 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.
  

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

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

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• 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 organisation 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: Norway > Oslo : Kjelsasveien 161 WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable