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Regulatory Specialist – Medical Devices Location: South Wales (Hybrid/Flexible working considered) Sector: Medical Devices We are seeking a Regulatory Specialist to join a growing Regulatory Affairs team within a medical device organisation operating across global markets. This role offers hands-on involvement across EU MDR, UK MDR, and international registrations, supporting both new product development (NPD) and lifecycle activities. This is an excellent opportunity for a regulatory professional looking to build depth in MDR/UKCA, work cross-functionally, and gain ownership of technical documentation and labelling activities. Key Responsibilities • Own and maintain product Technical Files and associated regulatory documentation across key global jurisdictions, • Generate and maintain key regulatory documents including Risk Management files, GSPR, Device Descriptions, and labelling, • Organise and supply documentation to support EU MDR submissions, registrations, and NPD activities, • Support resolution of regulatory-owned quality plans and contribute to economic operator agreements, • Identify applicable standards and external testing requirements, proposing regulatory strategies and options, • Lead the creation of labels and label templates, resolving operational labelling queries and supporting multi-site labelling projects, • Liaise with R&D, Quality, Operations, and other departments to support regulatory activities, • Create regulatory statements, rationales, and responses for internal and external stakeholders, • Maintain regulatory logs, databases, and documentation records, • Degree (or equivalent) in a scientific or engineering discipline, • Minimum 1 year of experience in Regulatory Affairs within the medical device industry, • Working knowledge of:, • EU MDR (2017/745) and UK MDR 2002 (as amended), • ISO 13485 (Quality Management Systems), • ISO 14971 (Risk Management), • Ability to work independently and collaboratively within cross-functional teams, • Strong written and verbal communication skills, • Participation in internal audit programmes, • Exposure to MDSAP countries and/or FDA regulatory systems, • Hands-on exposure to EU MDR submissions and global regulatory activities, • Opportunity to grow within a supportive and experienced Regulatory team, • Involvement across the full product lifecycle, from development to post-market, • A role that offers career progression, learning, and real regulatory ownership Apply now!

The role is responsible for leading a dedicated team of security engineers to deliver the implementation of modern SOC technologies across the Microsoft Security, Azure, CrowdStrike, and SentinelOne ecosystems. Ensure BlueVoyant customers receive world‑class service during Microsoft deployment act

The ideal candidate will drive go-to-market activities and client engagements around Microsoft technologies. This full-time position requires strong expertise in Microsoft Copilot and a proven track record in technical presales.

Microsoft, lot of experience, consultant. Join our team as a Microsoft Dynamics Sales Lead and become a key player in transforming financial services through innovative solutions. In this role, you will leverage your sales expertise to navigate the complexities of the Finance, Banking, and Insurance

We are supporting a high-profile organisation on a greenfield Microsoft Fabric initiative and are looking for an experienced Fabric Architect to lead the end-to-end platform design. If you have delivered Microsoft Fabric solutions at an architectural level, defining Lakehouse structures, medallion m

A well-regarded law firm in the UK is seeking an experienced Data Engineer to join their team amid a significant migration to Microsoft Fabric. The ideal candidate should have proven experience in data engineering with strong skills in Microsoft Fabric, SQL, and data governance.

Microsoft Dynamics 365 CRM Engineer.

This hands-on role involves configuring Microsoft Sentinel, optimizing detections, and driving improvements in security operations. Candidates should have strong experience with Microsoft Sentinel and KQL.

We are looking for an experienced Microsoft Systems Administrator to support in the expansion of our Microsoft M365 and Azure estate. Familiarity with Microsoft Defender for Endpoint and Microsoft Purview. Experience with responding to alerts using Microsoft 365 Security & Compliance Center.

You will play a crucial role in designing, implementing, and optimising solutions that leverage Microsoft's suite of low-code and no-code tools. You will be a champion of Microsoft's best practices and influence the team toward excellence. Expert-level knowledge of Microsoft Power Apps (Canvas and M

Proven experience with Microsoft 365, Microsoft Teams Phone, and the associated ecosystem. Microsoft Unified Communications Engineer. We are looking for a skilled Microsoft Unified Communications Engineer to join an ongoing project focused on delivering cloud-based communication solutions.

Relevant certifications such as Microsoft Certified: Azure Solutions Architect Expert, Microsoft Certified: Fabric Analytics Engineer Associate (DP-600), Implementing Data Engineering Solutions Using Microsoft Fabric (DP-700). As a Microsoft Fabric Architect at our consultancy, you will have the opp

If you know how to navigate the Microsoft Partner model, and thrive where strategy meets sales, this is the opportunity to step into a high-profile, growth-led role with real influence. If you love the Microsoft ecosystem, excel at building relationships that drive real outcomes, and want to represe

A leading recruitment firm is seeking an experienced Fabric Architect for a unique opportunity to shape the architecture of a new Microsoft Fabric data platform.

A cybersecurity firm is looking for a Manager in Microsoft Security Engineering to lead a team in delivering SOC technologies across various ecosystems. The ideal candidate will have over 10 years in cybersecurity, experience in team leadership, and strong knowledge of Microsoft solutions, making th

Einrichtung, Entstörung von Client- und Server-Systemen (Microsoft). Du bringst Erfahrungen in Microsoft Betriebssystemen sowie Hardware- und Software Kenntnisse mit.

Strong expertise in one or more Microsoft technologies such as:. Microsoft Azure (AZ‑104, AZ‑305, AZ‑400, etc. Relevant Microsoft certifications will be a strong advanta.

Demonstrated experience leading GTM initiatives aligned with Microsoft Azure in the region.

Microsoft Business Central (BC) Consultant – Remote- Contract role. For our international client, RED is currently looking for a Microsoft Business Central (BC) Consultant – Release & Deployment to join an ongoing project. Minimum 5 years of technical experience with Microsoft Business Central (

Business Development Director - Microsoft Dynamics & Cloud Solutions. Microsoft Dynamics 365 (ERP, F&O, CE, CRM). Microsoft Business Applications.

The successful candidate will possess strong knowledge of Microsoft Security technologies and AWS/Azure services, ensuring alignment with client needs.

The role requires strong technical skills in Microsoft Data & AI stack and excellent communication abilities for client engagement.

Manager, Microsoft Security Engineering, EMEA. Ensure BlueVoyant customers receive world-class service during Microsoft deployment activities and ongoing support. Drive improvements in people, processes, and technologies supporting Microsoft services implementation.

A leading training provider based in the United Kingdom is seeking an instructor to deliver training on Microsoft technologies such as Azure and Office 365. The ideal candidate will have strong expertise in Microsoft certifications, able to conduct hands-on labs, and must be willing to travel global

A leading technology services provider in the UK is seeking a skilled Microsoft Fabric Data Engineer for a remote position. The successful candidate will design, develop, and maintain data solutions using Microsoft Fabric, transforming data into actionable insights. Candidates should have expertise

Stay current with Microsoft updates, certifications, and new add-ons. Ongoing Microsoft certification and career development support. Microsoft Dynamics 365 Business Central Consultant.

Microsoft Copilot Studio Consultant. This is an exciting opportunity for someone who thrives on customer interaction, solution design, and hands-on build within the Microsoft ecosystem. Experience with Microsoft Power Platform and Copilot Studio.