Regulatory Affairs Team Leader
Regulatory Affairs Team Leader (12 month FTC)
Sector: Medical Devices/Diagnostics
Our client is a UK based company specialising in the branded consumer In-Vitro diagnostic products. The company is now looking for a Regulatory Affairs Team Leader to join the company on a 12 month fixed term contract to support with regulatory compliance of diagnostics products throughout the product life-cycle.
As the Regulatory Affairs Team Leader you will be responsible for:
· Ensuring regulatory compliance of in vitro diagnostic products and medical devices.
· Monitoring regulatory changes and implementing training on changing issues along with analysis of impact of regulatory changes on new and existing products
· Support with regulatory submission for new products within US/EU and Canada
· Support project teams in the understanding of regulatory demands and costings for new projects.
· Provide guidance on regulatory strategy and planning
Suitable applicants will have;
· Previous experience in a regulatory role within in vitro diagnostic (IVD) or Medical Device sector
· Experience working with ISO 13485, FDA regulations for medical devices and directive 98/79/EC and other international standards for IVD and medical devices
· Experience with US 510(k) submissions
· Excellent communication, writing and editing capabilities
· Educated to a minimum of BSc in a Life Science (or related) discipline or with equivalent industry experience.
Our client offers an opportunity to work for a leading medical device company on a permanent basis with a competitive annual salary and benefits package.