European Regulatory Affairs Specialist

Job details

European Regulatory Affairs Specialist: This exceptional medical devices company requires a highly competent European Regulatory Affairs Specialist to join their Midlands based team on a 6-9 month contract basis.The European Regulatory Affairs Specialist will take a critical role from day one, assuming responsibility for ensuring the compliance of a product portfolio with regulatory requirements in the EU and EFTA countries.

European Regulatory Affairs Specialist - key responsibilities:

• Prepare, collate and submit technical dossiers to National authorities in Belgium, Switzerland and other European countries as appropriate
• Build a supporting electronic document management system for Product Directive submissions
• Support the company in gaining access to regulatory data for key activities
• Drive forward the building of pre-registration packages to meet regulation requirements

European Regulatory Affairs Specialist - qualifications, skills and experiences:

• Good academic background with a degree level qualification in a relevant discipline
• Proven regulatory experience including the preparation of relevant regulatory documentation
• Membership of relevant professional association is highly desirable
• Competent IT user
• Exceptional communication / interpersonal skills
• Knowledge of another European language would be a nice to have, Spanish being a distinct advantage
• Experience of supervising staff

European Regulatory Affairs Specialist: This is a superb opportunity for a Regulatory Affairs Specialist to demonstrate their capabilities on a contract basis within a well recognised and high quality company.

Apply now or contact Michael for more information.