Posted Mar 20 2019
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How many times in your work do you get to save a life? At Current Health, you get to build and create technology that does this every single day. Current Health helps healthcare teams to monitor and manage patient's in their own home. We shine a light on human health outside of the hospital, delivering unprecedented insight's to healthcare professionals and surfacing those who are at high risk of illness before they deteriorate. Current Health uniquely brings together experts in artificial intelligence, biomedical engineering, electronics and software engineering, product design and clinical operations to deliver a technologically and scientifically complex platform globally.
About the role
This new role created within the regulatory and quality team will require a combination of regulatory, quality and operational skills to enable innovative products that save lives to be developed and deployed ensuring required legislation is met.
As part of the regulatory & quality team, reporting into the VP RA/QA, you will take responsibility in maintaining and enhancing our operational and quality systems, be required to have an input into new and existing projects, regulatory submission and advise on changing regulations and their impact on projects.
You will be working with a growing team to help shape regulatory and quality pathways for the registration of products across territories in a fast-changing and exciting environment, utilising your expertise to guide our team in interpreting policies and regulations assure compliance by default.
Working with the VP RA/QA, you will ensure the quality system is kept up-to-date and will take the lead on audits and inspection preparation, ensure successful resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits.
• Owning the QMS and building on the current structures to ensure regulatory and business expectations for our current and future products are met
• Collaborate with product and engineering teams to ensure all products meet the applicable regulatory requirements and develop and maintain technical documentation for current and future developments
• Augment and improve the QMS to reflect both best practices and internal development process
• Maintain our organisational knowledge of laws and regulations, provide oversight of current and evolving regulatory requirements to ensure the QMS remains current
• Establish and improve product lifecycle processes to ensure quality is maintained at the heart of our development strategy
• Be an active participant in the product development lifecycle, including leading on risk management and providing advice to development teams
• Manage post market surveillance activities, complaints, field safety corrective actions, product recalls and medical device reporting of adverse incidents and evaluate to determine any regulatory actions required
• Write and edit technical documents
• Supporting the implementation and management of the eQMS systems
• Perform internal audits and assessments as applicable. Ensure readiness for and hosting Notified Body audits.
• Evaluating and monitoring sub-contractor compliance and maintaining Technical Agreements as appropriate.