Senior Specialist Regulatory Affairs

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 SmartSheet 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

In specific locations the pay range may vary from the range posted.

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