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 & Gamble (P&G)
and
Abbott ; 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
Regulatory Affairs Specialist - Innovation in London employer: SPD Development Company Ltd
At SPD Swiss Precision Diagnostics, we pride ourselves on being an exceptional employer that fosters a culture of innovation and collaboration in the heart of Bedford. As the Head of Assay, you will not only lead a dynamic team dedicated to developing groundbreaking diagnostic products but also benefit from our commitment to employee growth through tailored coaching, performance management, and a supportive work environment. Join us to make a meaningful impact while enjoying the unique advantages of working within a joint venture that champions scientific excellence and personal development.
Contact Details:
SPD Development Company Ltd Recruitment Team
