Senior Regulatory Affairs Officer

At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba–– our blood bank reagents portfolio–– and MosaiQ®–– one of the first multiplexing and multimodality automated testing platforms––are designed to make labs more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life. This role is with our Alba business unit, relating to in vitro diagnostic devices for blood grouping

AliveDx is recruiting for a Senior Regulatory Affairs Officer to join the Regulatory Affairs Team based near Penicuik, Edinburgh. The role is a full-time permanent position, working 37.5 hours.

The Senior Regulatory Affairs Officer is responsible for leading and executing regulatory strategy for AliveDx products across multiple geographies. The role ensures the identification, interpretation and application of applicable regulatory requirements, proposes compliant regulatory solutions, and independently manages complex product license registrations and lifecycle activities worldwide.

The role provides expert regulatory guidance to cross-functional teams, acts as a key point of contact with regulatory authorities, and supports continuous improvement of regulatory systems and processes.

The Senior Regulatory Affairs Officer also has responsibility for mentoring and supporting junior regulatory staff, contributing to capability development within the Regulatory Affairs function.

Your main responsibilities will include:

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• Prepare and maintain regulatory documentation and materials in compliance with Good manufacturing practice (cGMP), ISO13485, the IVD Directive 98/79/EC, the IVD Regulations (EU) 2017/746, FDA 21 Code of Federal Regulations (CFRs), Canadian Medical Device Regulations (CMDR) SOR/98-282 and any other applicable country-specific regulations.
  
• The Senior Regulatory Affairs Officer will liaise with internal team members, regulatory agencies and external customers/distributors to provide information to support regulatory processes and to confirm compliance issues.
  
• Maintain excellent working knowledge of regulatory requirements, keeping abreast of updates to regulation worldwide and advise as appropriate.
  
• Liaise with any and all regulatory agencies and external customers/distributors/vendors to provide information to support regulatory processes and to confirm compliance issues.
  
• Advise project team members on regulatory requirements, data and information required for successful license applications, impact of changes to existing product and impact of non-conformances and post-market events.
  
• Ensure the accurate recording and satisfactory completion of all departmental documentation including documenting revisions through a change control process.
  
• Contribute to the design and implementation of new quality systems and procedures and identify areas for potential improvement to ensure continuous quality improvement is realised.
  
• Supervise colleagues within the Regulatory Affairs department, when required, by providing support and guidance as needed to keep knowledge across the team remains current.
  

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• Extensive experience preparing, reviewing, and maintaining regulatory documentation, with strong knowledge of global IVD regulatory frameworks and standards and excellent technical writing skills. (Experience of preparing and submitting regulatory applications in geographies out with EU, US, Canada)
  
• Confident, clear communicator with the ability to engage effectively with regulatory authorities, notified bodies, customers, and external partners.
  
• Proactive and detail-oriented professional with strong analytical and risk-based problem-solving skills, capable of managing multiple priorities independently while meeting deadlines and driving continuous improvement.
  
• Minimum of 5 years experience writing full IVD regulatory submissions (Particularly EU IVDR, 501 (k) and BLA)
  

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• A highly dynamic and growing environment.
  
• An opportunity to live your passion for intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do.
  
• A flexible working environment where applicable and a range of core and flexible benefits ranging from private medical cover, life assurance, additional annual leave, cycle to work, technology benefits, experience days and access to marketplace discounts.
  

This role is not eligible for Visa Sponsorship, applicants must have the right to work in the UK.

Interested? We look forward to receiving your application.

AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, region/belief, sexual orientation or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business needs.