Senior Regulatory Affairs Officer

AliveDx Suisse SA; Penicuik; On-site; GBP 50,000 - GBP 70,000; Full time

Job summary

A leading diagnostic insights company based near Penicuik, Edinburgh, is looking for a Senior Regulatory Affairs Officer. This full-time role involves leading regulatory strategy for products internationally, ensuring compliance with various regulations, and mentoring junior staff. You will liaise with regulatory authorities, manage license registrations, and contribute to continuous improvement of regulatory processes. The position offers a dynamic environment with flexible benefits including medical cover and additional annual leave.

Benefits

Private medical cover

Life assurance

Flexible working environment

Access to marketplace discounts

Qualifications

• Experience with regulatory strategy execution across multiple geographies.
• Ability to identify and apply regulatory requirements.
• Strong communication skills with internal and external stakeholders.

Responsibilities

• Lead regulatory strategy for product approvals worldwide.
• Maintain regulatory documentation compliant with cGMP and ISO standards.
• Supervise junior regulatory staff and contribute to their development.
• Liaise with regulatory agencies for compliance and guidance.

Skills

IVDR implementation experience

Regulatory application preparation

Excellent knowledge of regulatory requirements

Ability to provide regulatory guidance

Job description

Overview

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.

AliveDx is a company empowering diagnostic insights, transforming patient care, and innovating 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.

Senior Regulatory Affairs Officer

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 Mission

Your main responsibilities will include:

• 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 knowledge across the team remains current.

Your Competencies

• Previous experience of IVDR implementation plans and requirements
• Experience of preparing and submitting regulatory applications in geographies outwith EU, US, Canada.

What We Offer

• 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, experience days and access to marketplace discounts.

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.