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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.

Post market surveillance engineer

AliveDx is recruiting for a Post-Market Surveillance Engineer to join the Post-Market Surveillance team based in Penicuik, near Edinburgh, possibility of fully remote.

The Post-Market Surveillance Engineer plays a pivotal role in ensuring the company’s In Vitro Diagnostic (IVD) products remain safe, effective, and compliant throughout their lifecycle. This position is responsible for establishing, maintaining, and continuously improving post-market surveillance (PMS) processes, complaint handling, vigilance/adverse event reporting, and Field Safety Corrective Actions (FSCAs)/recalls in line with IVDR 2017/746, ISO 13485:2016, and MDSAP requirements.

The role is a full-time, temporary position working 37.5 working hours.

YOUR MISSION

Your main responsibilities will include:

• Lead and execute Post-Market Surveillance (PMS) activities, including preparation and submission of PMS reports and Periodic Safety Update Reports (PSURs).
• Manage complaint handling processes, ensuring timely intake, investigation, documentation, and closure according to regulatory and internal requirements.
• Coordinate vigilance and adverse event reporting activities, ensuring compliance with EU IVDR 2017/746, FDA, Health Canada, and other relevant regulatory requirements.
• Oversee Field Safety Corrective Actions (FSCA) and product recalls, including risk evaluation, communication with competent authorities, and implementation of corrective actions.
• Collaborate with cross-functional teams (Regulatory Affairs, R&D, Manufacturing, Clinical Affairs) to drive continuous improvement in product safety and performance monitoring.

YOUR COMPETENCIES

• University degree in Biomedical Engineering, Life Sciences, Quality Management, or a related field.
• 3–5 years of hands-on experience in a Quality/Regulatory role within the IVD or Medical Device industry.
• Previous direct interaction with regulatory authorities (e.g., Notified Bodies, FDA, Competent Authorities).
• Strong knowledge of:

IVDR (EU) 2017/746

ISO 13485:2016 Quality Management Systems

MDSAP requirements (with focus on PMS and vigilance)

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.