Quality and Regulatory Affairs Specialist

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.

REGULATORY COMPLIANCE OFFICER (POST-MARKET SURVEILLANCE) (12 MONTHS)

AliveDx are recruiting a Regulatory Affairs Officer to join the Regulatory Affairs team based near Edinburgh (EH26 0BF). This role is Hybrid however we can consider fully remote for the right cadidate. The purpose of the role is for implementing and maintaining regulatory compliance processes including regulatory evaluation of non-conformances, post market surveillance, vigilance and associated reporting, regulatory and standard watch. The role is responsible for coordinating the HHE activities that may be required based on individual non-conformances or product complaints.

YOUR MISSION

Your main responsibilities will include:

• Preparing and compiling regulatory documentation, coordinating and executing regulatory submission in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Medical Device Approvals (510(k)), and other country requirements as appropriate.
• Advising AliveDx staff and project team members on data and information required for successful license applications and coordinating their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
• Ensure Quality Assurance release of incoming goods, intermediate and final product obligations for AliveDx Suisse SA
• Interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting).
• Interface with Competent Authorities for reporting incidents and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting), BPDR (biological products deviation reports)
• Evaluate Product/Processes Non-Conformances, determine whether their need to be reported to the Competent Authorities.
• Evaluate Product/Processes Non-Conformances, determine whether their need to be reported to the Competent Authorities.

YOUR COMPETENCIES

• A relevant degree and/or relevant work experience in a regulatory affairs environment.
• Experience in medical device/IVD/Biotech industry
• Experienced in meeting with, making presentations to, and negotiating with regulators
• Experienced in meeting with, making presentations to, and negotiating with regulators.
• Specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics (93/42/EC, 98/79/EC directives, 510(k), PMA, BLA, CMDR, etc..).
• Great attention to detail, communication and collaboration skills.

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 pension, 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.