Regulatory Affairs Manager

CPL

WICKLOW

Regulatory Affairs Manager. On behalf of my client, I am recruiting for a Regulatory Affairs Manager. The successful candidate will be tasked with the effective management of the regulatory affairs team to prioritize regulatory workload based on compliance and business objectives, while working with management to make regulatory decisions. In addition, the RA Manager will also be responsible for leading the companys IVDR program. This role will begin with a 12-month contract, with the possibility to be made permanent. Responsibilities: Provide leadership, guidance and ultimate decision making for the Regulatory Affairs team. Manage and lead the project for implementation of the new IVDR regulation at the Bray site. Ensures the accurate and timely preparation of regulatory submissions and reporting in accordance with Company goals and regulatory requirements. Provide regulatory assessments and plans for international product registrations and approvals. Stay abreast of EU, US, and global IVD regulations and guidance. Manages the preparation and timely submission of regulatory documents. Ensure quality and compliance of regulatory activities by adhering to established corporate and functional processes, guidelines and SOP's. Work closely with Sales and Marketing. Collaborating with Corporate Vice President of Quality & Regulatory Affairs to provide regulatory assessments and plans for international product registrations and approvals. Qualifications/Experience: Primary degree qualification in a science, engineering or regulatory affairs. Minimum 5 years experience in in-vitro diagnostics or related industry. Previous leadership experience. Experience with effective project team leadership and management oversight. Leadership capabilities working across varied cultures, expertise and backgrounds. Knowledge of EU and FDA regulations and guidelines, and the ability to provide interpretations of the information to others. Ability to identify and drive regulatory compliance improvements. Highly organised, with the ability to effectively prioritise tasks. If you are interested in applying for this role, please call Ciara on +353 1 2784671 or email cphillips@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com.

1386 days ago