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.
QUALITY & REGULATORY AFFAIRS SPECIALIST
AliveDx are recruiting a Quality & Regulatory Affairs Specialist to join the Regulatory Affairs & Quality Department. The Regulatory Affairs & Quality Department primary role is to establish the Quality/Regulatory link between AliveDx products and the end user. Reporting to the Chief Regulatory Affairs and Quality Officer, the Quality and Regulatory Affairs Specialist is responsible to deliver end to end regulatory package under ODM-Distributor scheme in compliance with established quality management system, overseeing (but not limited to) initial compilation of design control evidences, supplier management, incoming inspection and product release process, product submission, post-market surveillance, vigilance and associated reporting.
The role is a full-time, temporary position for 12 months which can either be based in our ARC facility near Edinburgh EH26 0BF (working 37.5 hours per week) or in Eysins in Switzerland (working 40 hours per week).
YOUR MISSION
Your main responsibilities will include:
* The role is responsible for maintaining product and site regulatory & quality compliance to maintain license/registration once granted.
* The role is also responsible for supporting other regulatory and quality affairs team members as needed, including training and guidance as appropriate.
* 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.
* Ensuring Quality Assurance release of incoming goods, intermediate and final product obligations for AliveDx Suisse SA.
* Ensure Supplier management obligations for AliveDx Suisse SA.
* Ensure Post-market surveillance obligations for AliveDx Suisse SA.
* Ensure vigilance reporting obligations for AliveDx Suisse SA.
* Be a point of contact for regulatory & quality compliance issues
* Interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting).
* Evaluate Product/Processes Non-Conformances, determine wether their need to be reported to the Competent Authorities.
* Support QMS organization during regulatory inspections or certifications audits.
* Perform any other duties as reasonably requested from the Company from time to time.
* Conduct all duties in compliance with company Quality Management System and cGMP, GCP and ISO13485 requirements.
YOUR COMPETENCIES
* Master’s degree or equivalent in life sciences and significant experience in a regulatory/quality role.
* Experience in medical device / IVD / biotech industry.
* Experienced in meeting with, making presentations to, and negotiating with regulators.
* Significant 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, CMDR, etc).
* Specialist knowledge of vigilance processes for US, EU and other jurisdictions as appropriate (MDR, MEDDEV 2.12, etc.)
* Effective time management and prioritization skills.
* Ability to work in an international team in a fast-paced changing environment.
* Great attention to detail with a thorough and methodical approach to work.
* Communication 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 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.
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