Regulatory Affairs Department Leader
Company client recruiting a Regulatory Affairs Department Leader for a commercial stage diagnostics company. The role is responsible for ensuring the continued registration for all their products after initial registration or approval by liaising with regulatory bodies to confirm compliance issues and to provide this information to the appropriate staff groups. The role is responsible for acting as an active participant in team meetings that relate to changes to developed products that will require further registration and regulatory submissions.
• Serve as a member of the Regulatory and Quality Management Team for oversight and guidance of the entire organization on RA and QA strategy and activities
• Manage, prepare and maintain regulatory documentation to enable the Company to comply with ISO13485 standard and to ensure on-going regulatory compliance.
Significant specialist knowledge of regulatory affairs as applied to in vitro diagnostic medical devices and an understanding of the operation of a medical device manufacturing establishment
Understanding of budgetary process and requirements for managing a department.
A relevant degree or professional qualification and extensive experience in a regulatory affairs environment.
Company client operates as both a Recruitment Agency and a Recruitment Business. We endeavour to reply to all applications when possible however on occasions this may not be possible due to volumes of responses. Client is a Scientific, Engineering and Manufacturing Recruitment business supplying talented staff to permanent and temporary opportunities.