Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist

Abbott Diabetes Care

Witney, Oxfordshire

Competitive Salary + Excellent Benefits

Abbott Diabetes Care designs, develops and manufactures leading-edge glucose monitoring systems and test strips for use in both home and hospital settings. Our product portfolio includes Freestyle Libre, a recently launched system that is revolutionising how people with diabetes around the world monitor their glucose levels. We are passionate about doing work that improves the quality of people’s lives.

We currently have an opportunity for a Principal Regulatory Affairs Specialist to join our team, based in Oxfordshire, supporting the significant manufacturing capacity expansion underway at the Witney site plus other Operational and R&D projects.

Primary Job Function

This position is responsible for planning, creating and implementing solutions for regulatory registration and release of products for distribution into specific geographies.

Core Job Responsibilities

• Executes and Ensures Product Registration,
• Release Authorization and Release for Distribution.
• Oversee processes and team involved with obtaining and maintaining product registration, release authorization and release of product to specified geographies.
• Coordinates with cross functional teams including but not limited to: US Regulatory, International Regulatory, Marketing / PLC, Supply Planning, Customer Service, Quality, R&D, Operations, etc. to ensure all internal and external requirements are met prior to product release.
• Identify risk areas and escalate issues as appropriate.
• Manage multiple programs with minimal oversight.
• Product Release Process Ownership
• Develops processes and tools to support controlled product release. Responsible for development, maintenance and compliance with applicable Corporate and Divisional Policies and procedures.
• Product Registration, Release Authorization and Release Planning
• Provide Regulatory input to product lifecycle planning
• Provide Regulatory input to strategy based upon regulatory changes
• Identify and react to emerging issues
• Analyse product-associated problems and develop proposals for solutions Acts as a liaison with other departments, e.g., Quality, R&D, Legal, Operations, Marketing and Clinical Affairs, for major initiatives.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback.
• Maintains a safe and professional work environment.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Position Accountability / Scope

• Ensure timely registration of all current and new ADC products with the appropriate regulatory authorities.
• Plan and manage the non-project-related workload of Regulatory team members to maintain efficiency and alignment with departmental goals.
• Oversee the accurate and efficient management of regulatory systems to ensure traceability and accessibility of records for future reference.
• Supervise Regulatory team members in developing strategies for both project and non-project-related workstreams.
• Support the line manager in shaping and executing departmental-level Regulatory strategies.

Minimum Education

• Educated to degree level or equivalent preferably in a Scientific discipline e.g., Chemistry, life Sciences, Biology.

Minimum Experience/Training Required

• The ideal candidate will hold a degree (or equivalent qualification), preferably in a Science or Engineering discipline, and will have prior experience in Regulatory Affairs within the Medical Device or In Vitro Diagnostics (IVD) sector.

We are particularly looking for individuals with:

• A solid understanding of the EU Medical Device Regulation (MDR – Regulation (EU) 2017/745) and/or the In Vitro Diagnostic Medical Device Regulation (IVDR – Regulation (EU) 2017/746)
• Experience working within an ISO 13485-certified Quality Management System
• Proven international registration experience, ideally with a focus on Asia Pacific markets
• Proficiency in Chinese is considered a strong advantage

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