PMS/Risk 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.

 Post Market Surveillance/Risk Specialist

AliveDx are recruiting a PMS/Risk Specialist to join the Quality team based near Edinburgh (EH26 0BF). The focus of this position is to ensure, through completion of the relevant Product Risk and Product Post Market Surveillance (PMS) activities, that Alba Bioscience products are maintained in compliance with all relevant Regulations. As part of this job, the PMS/Risk Specialist will manage risk throughout the entire Design Control Process for new projects and through Core QMS processes (such as Non-Conforming Product management, Change Management, Complaint Management) for Products on the market.   

YOUR MISSION

Your main responsibilities will include:

• Ensure Product Risk Management Processes are compliant with relevant Risk Management Regulations.
• Conduct all duties in compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirement
• Perform any other duties as reasonably requested from the Company from time to time.
• Providing support, guidance and training as needed to fellow team members in the areas of Risk Management and PMS
• Contribute to the regulatory watch process by maintaining knowledge of new or update regulatory requirements, guidance documents and industry standards relating to your related areas of responsibility
• Participate in regulatory inspections or certification audits as part of the Quality Systems Team
• Promote risk culture within Alba including Risk Based Approach and Continuous Improvemen
• Act as a Risk Management Team Representative during Third Party Audit
• Ensure Product Risk Management & PMS Process efficiency according KPIs.
• Create and/or update PMS documentation in line with IVDR requirements and in accordance with the agreed PMS schedule (PMS Plan, SSP, PMS Report, PSUR)
• Carry out Post Market Surveillance (PMS) activities for Alba Bioscience products in adherence with the required schedules to ensure regulatory compliance
• Create new and update existing Product Risk Management Documentation to ensure compliance with current procedures
• Lead and/or support all Product Risk Management activities according to current procedures

YOUR COMPETENCIES

• Science Degree or Equivalent qualification

• Experience in risk management

• Experience carrying out Post Market Surveillance activities (PMS)

• Ability to prepare coherent regulatory reports

• 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.