Regulatory Affairs Specialist - Innovation

Regulatory Affairs Specialist - Innovation Location: Bedford The Vacancy Swiss Precision Diagnostics (SPD) is a world leader in the research, design and supply of advanced consumer diagnostic products. SPD is a joint venture between Procter and our brand Clearblue , is recognised worldwide for delivering accurate home pregnancy and fertility monitoring tests. We are looking for a Regulatory Affairs Specialist - Innovation to join our Regulatory Affairs team on a Full-Time, Permanent Contract . The role will be based at our Innovation Centre in Bedford, UK with an option for Hybrid Working . The Regulatory Affairs Specialist role supports the development and execution of regulatory strategies for new product development projects and business development opportunities as directed by the Regulatory Affairs Manager - Innovation and the Global Regulatory Director. The role fundamentally provides technical regulatory knowledge and guidance on global regulations, specific to In Vitro Diagnostic Medical Devices (IVD) and Medical Devices (MD). A As part of this, the role supports regulatory strategy implementation, market access activities, regulatory intelligence and surveillance activities, and the assessment of emerging regulatory requirements, standards and industry trends. The role supports innovation projects from concept through to commercialisation, including third party sourcing opportunities. Working alongside the Regulatory Affairs Manager - Innovation, the role provides regulatory guidance to cross functional teams and supports the identification of compliant, practical and efficient solutions to regulatory challenges. We're looking for someone who holds a minimum of BSc degree or equivalent experience in life sciences (e.g. biological sciences, biochemistry, pharmacology etc.) and has hands-on experience in the IVD or Medical Device Industry . The role holder should have good working knowledge of ISO 13485, IVDR (EU 2017/746), MDR (EU 2017/745) and FDA regulations for medical devices, and other international standards and regulations for IVD and medical device products . Experience of working with Notified Bodies and Regulatory Authorities , supporting product development activities and preparing regulatory submissions and technical documentation would be highly advantageous. The role holder will be expected to represent the company to the highest professional standards so good interpersonal skills and excellent written and oral communication skills are essential along with the ability to communicate complex technical information clearly. We can offer you: Hybrid working Annual discretionary bonus 25 days paid annual leave plus bank holidays Company pension scheme including competitive employer's contribution Private Medical Insurance package with additional medical cash plan scheme Enhanced maternity and paternity pay Company supported employee Health