Reference Number: JO-2107-471649
Senior Regulatory Manager
Job Type: Permanent
Senior Regulatory Manager
Flexible with work from home
My clients rapid diagnostics business is helping more people around the world stay healthy through portable, affordable, and convenient testing. The RDx business consists of 5 areas – Infectious Diseases Emerging Markets, Infectious Diseases Developed Markets, Toxicology, Cardiometabolic, and Consumer Products & Services.
Strengthening our Regulatory Affairs team, we have a new and exciting opportunity for a Regulatory Affairs Manager to join us on our growth journey. The Regulatory Affairs Manager is the UK Responsible Person for ARDx, and will act as the lead interface with the MHRA and other associated Regulatory Bodies.
In this role you will be responsible for providing regulatory strategy and leadership to enable the UK and Ireland business to support key ARDx projects and ongoing Business Unit regulatory activities in a manner that is compliant, and customer focused.
Key responsibilities include:
Development and implementation of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
Provides Divisional Regulatory leadership, support and guidance for key Divisional and BU projects to ensure that activities are achieved in a timely and regulatory compliant manner and maintained within budgetary limits.
Ensures the provision of training in Regulatory Areas that impact key ARDx teams and projects.
Responsible for the provision of issue specific Divisional and Business Unit RA guidance and assessment of business issues to mitigate and effectively manage any adverse effects where possible.
Responsible for external and internal Regulatory influencing and communication to more effectively achieve long-term business aims as set by Director, Division Regulatory Affairs
Responsible for the provision of regulatory and other support for EU and UK Authorized Representative functions as needed.
To be successful, you will be an experienced Regulatory Affairs professional, ideally gained in Diagnostics or IVD Medical Devices business, and hold a Bachelor’s degree, preferably in quality, science or a closely related discipline.
The ideal candidate will be a proactive individual who takes initiative and is able to work within a small team, but also interact on a wider business scale. You will need to have excellent communication and time management skills, and be comfortable working in a fast-paced, changing and dynamic environment. Managing a small team, you will coach, develop and mentor others, driving functional capability and strategic advantage.
As youd expect from an innovative global healthcare company, we offer an excellent starting salary, and a competitive range of benefits.