Regulatory Affairs Specialist

Optimus Search Limited
40,000 - 60,000
06 Oct 2017
07 Nov 2017
Contract Type
Full Time
Role Title: Senior Regulatory Affairs SpecialistLocation: YorkshireJob Type: PermanentSalary: 50,000 (Dependent on Experience) Summary My client is looking for a Senior Regulatory Specialist to join at their Yorkshire location. This is a great opportunity to further your career, gaining exposure to a broad range of pharmaceutical products, at a fantastic company.The main responsibilities of this role are: * Prepare and review regulatory dossiers for medicinal products and clinical trials in compliance with EU and international market regulations * Ensure consistency in presentation of information through compilation and review of documentation * Coordinate with and meet requirements of the companies other departments * Oversee and advise project teams to ensure regulatory requirements are met * Develop strategies to ensure relevant data is generated * Coordinate with external authorities to ensure approvals are obtained in a timely manner * Keep up to date with changing market regulations and legislations * Review and approve change control impact assessments for product lines * Maintain compliance with GMP, FDA Quality System and ISO 13485 standards You will: * Ideally have a honours degree in science or a related field * Have substantial regulatory compliance experience with a strong medical devices background * Substantial regulatory experience within a regulatory compliance function and with a medical devices background * Have good knowledge of current regulatory legislations in international markets relevant to similar companies * Have good communication skills and a team-driven attitude * Have the ability to manage a team and share expertise * Be able to manage several tasks and projects at once, with strong organisational skillsDon’t miss out on the opportunity to join a global company in a fantastic role- apply today! Email your CVs to