Regulatory Manager

Description

Regulatory Affairs Manager - North East

The day-to-day management of the Regulatory Affairs functions of the Company.

• Ensure the company and the company's products are compliant with appropriate regulations
• Monitoring and setting timelines for license variations and renewal approvals
• Provide clear, constructive regulatory advice and guidance to global project and product development teams.
• Facilitate alignment with Quality, Marketing and Assay Development groups to support communication and information sharing; with the goal of delivering high quality submission packages.
• Ensure Assay Development activities are aligned with regulatory requirements and timelines that are commensurate with regulatory submission objectives.
• Define regulatory strategy in conjunction with the Group QA/RA Manager; and drive implementation of the strategy for regions of commercial interest to the company.
• Negotiating with regulatory authorities for marketing authorisation
• Manage the creation and development of Technical files for the EU IVD Directive
• Preparation of regulatory submissions for EU and US. Provide support to authorised representatives for regulatory submissions in countries such as Canada, Japan, China and other countries that implement marketing regulations.
• Manage and maintain Device registrations.
• Review all labelling, marketing and training materials for regulatory compliance.
• Regulatory input into the change management and complaint handling systems, in support of lifecycle management.
• Manage Post-market surveillance and vigilance activities.
• Maintain awareness of regulations and guidelines governing the company and communicate their impact on existing and future product registrations.
• Plan, budget for, and maintain adequate resources necessary to efficiently execute RA operations

Experience

• Minimum of 5 years experience in Regulatory Affairs functions related to medical devices (preferably IVD) or other regulated healthcare industry. At least 2 of the 5 years should have been spent in a managerial position
• Experience of line management
• Proven experience in hosting or supporting third party and regulatory body audits/inspections
• HR: Grow, motivate and develop a high performance team in support of priorities and strategies. Attract, recruit and retain required members not currently in place. Provide mentoring to enable a strong culture of collaboration, entrepreneurship, and achieving results while ensuring the integration of quality and service in day-to-day operations.
• Finance: responsible for strengthening of business sense throughout any decision making.
• Experienced in dealing with Worldwide Regulatory Affairs in the IVD or Medical Device industry.
• Experience of preparing regulatory submissions in EU, US, China, Middle East and ROW

If you are interested please send an updated version of your CV or contact Bethany on