Regulatory Operations Associate

About the role

As Regulatory Operations Associate, you will be responsible for supporting regulatory activities for the compilation, preparation, review and submission of regulatory documents to Notified Bodies and where applicable Health Authorities to support the launch of new innovations, roll outs of new and existing products, maintain local licenses and maintain regulatory compliance though out product life cycle.

As a key member of our Global Regulatory Operations team within the Regulatory and Safety Function, your key responsibilities will include:

• Delivering medical device dossier and registration documentation, supporting regional and global market registrations in collaboration with local regulatory teams.
• Delivering compliance-related activities by providing regulatory guidance to ensure the change can implement according to plan. Proactively address unforeseen issues and deliver timely regulatory solutions to maintain compliance and project timelines.
• Ensuring operational excellence for your area of responsibility and align on priorities and resourcing with the Regulatory Operations Manager for Medical Devices.
• You will form part of the Regulatory Operations team and will connect with the RAS Strategy teams and project teams where input from your department is required.
• You will be a critical partner of cross-functional colleagues across the Regulatory Strategy and Operations, Consumer Safety, Risk Management/Vigilance, R&D, and Quality across Reckitt to ensure on time and compliant generation of data for medical devices dossier generation and dossier review.
• Ensure that you work according to internal and external standards, to ensure our dossiers are compliant according to external regulations and internal standards.

Your responsibilities

• Responsible for the creation, delivery and maintenance of medical device regulatory dossiers in line with the agreed regulatory strategy to achieve in market registrations/launches as per planned timings and existing pipeline compliance.
• Work in partnership across RAS teams to develop, communicate, and implement the regulatory strategy in collaboration with cross-functional project team and aligns on content of the regulatory submission. Prepare and support submission of registration dossiers whilst ensuring global activities are appropriately assessed for world-wide implications.
• Support and deliver training to business partners, materials that optimally prepare the business for the present and future regulatory environment.
• Work in partnership across RAS teams to develop, communicate, and implement the regulatory strategy in collaboration with cross-functional project team and aligns on content of the regulatory submission. Prepare and support submission of registration dossiers whilst ensuring global activities are appropriately assessed for world-wide implications.
• Ensuring you work in partnership with other X-functional technical functions like Safety, Quality, Medical, Marketing, Supply, Packaging and R&D as well as other RAS areas and local teams to define requirements for submissions in efficient and timely manner.
• Be responsible for coordinating responses to questions received from regulatory authorities.
• Lead projects with a clear understanding of a broad set of registration/regulatory requirements across multiple markets meeting project objectives and milestones.
• Accountable of delivering project results following Reckitt’s processes and procedures. Responsible of communicate risks and progress with guidance.
• Understanding of internal business and regulatory processes.
• Responsible for authoring and reviewing departmental SOP/work practices.
• Seek opportunities to drive simplification and opportunities.
• Support audits and audit readiness, both internal and external to Reckitt, with a good level of knowledge in Regulatory guideli