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Regulatory Affairs Specialist

Scientific Supplier
Regulatory & Compliance
Regulatory Affairs
London
£Contact Libby
Scientific Supplier - Diagnostics

Role Overview

The Regulatory Affairs Specialist will report to the Commercial Director. This is expected to be a hybrid role, 3 days per week working from home and 2 days based in EUROIMMUN UK’s offices in Wimbledon, South-West London. A key aspect of this role is to be informed of all new and existing legislation in relation to the sale of diagnostic products on the UK market.

Company Information

The Regulatory Affairs Specialist will be responsible for actively supporting the Commercial team to ensure that the products and related documentation are compliant to the national and international requirements.

Role Requirements

– Support the planning and execution of regulatory activities for the registration of the assigned product portfolio
– Serve as a subject matter expert for creation of regulatory reports and regulatory requirements.
– Drive results through being a well-organized team player with a focused and disciplined approach to achieve the joint goals
– Collaborate with our headquarters in Germany and our national subsidiary
– Support all pre-market and post-market regulatory activities of the assigned product portfolio
– Keep track of the national and international requirements for product registrations
– Work with the product teams to ensure the products and related documentation are compliant with the regulatory requirements
– Support the national and international Regulatory Affairs teams with national MHRA registrations and the regulatory transformation for compliance to the new EU IVD Regulation 2017/746
– Create registration dossiers used for registration at international authorities
– Be actively involved and contribute from the regulatory perspective to compliance of the company to any relevant standards including but not limited to ISO27001 and ISO9001

Person Specifications

-BSc (or equivalent), medical technology or related field
-Regulatory affairs and quality management
-Fluency in English
-Laboratory Experience
-Proven business acumen
-Experience in the in-vitro diagnostics sector

Package

Salary – competitive depending on experience
Working location – Hybrid role – 3 days office / 2 days WFH.
Annual Leave – 24 Days per year (excluding B/H), increasing by 1 day for every completed Calendar Year (Jan-Dec) up to a maximum of 29.
Birthday off – 8 hours TOIL (Time off in Lieu) = 1 x day.
Pension – 4+4% – auto enrolment after 3 months.
Medical Insurance: AXA Medical Aid scheme – opt-in option after probation period.
Group life cover.

Locations

Clapham
Putney
South West London
Wandsworth
Wimbledon
Previous Listing
Date Updated
20 Nov 2023
Job reference
71610
Categories
Full Time
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