Regulatory and Quality Lead

Regulatory and Quality Lead

Posted Mar 20 2019

Edinburgh

Full time

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What will you do

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.

Responsibilities:

• 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.

About you

  • Experience of start-up culture and ways of working is beneficial
  • Experience of leading risk management activities, utilising best practice techniques (ISO 14971)
  • You will have proven experience of working within the medical device industry and taking responsibility for regulatory submissions and the quality system, including internal audits and quality reviews (lead auditor beneficial, but not essential)
  • Recent experience with complex electronic, electro-mechanical and a software as a medical device, in particular wearable devices
  • Strong and practical knowledge of ISO 13485, FDA CFR 820, MDD and MDR as well as emerging standards and regulations i.e. MDSAP and FDA Pre-Certification Program
  • Strong experience in Regulatory Affairs and/or Quality with demonstrated experience in authoring and submitting complex regulatory submissions (Technical Documentation, 510(k), De Novo/PMA)
  • You will have experience and understanding of medical devices standards, including IEC 60601(-1, -2), ISO 62304, ISO 62366 and labelling requirements
  • Exposure to dealing with local and international regulatory agencies
  • Experience in medical device regulatory affairs including knowledge of reporting and vigilance requirements in different territories
  • You will have a degree or equivalent in a related field in engineering, in particular biomedical engineering
  • You will have previous experience in a QA/RA role relating to medical devices and Technical file compiling
  • Comprehensive understanding and training with ISO14971 Risk Management
  • You will have the ability to solve regulatory problems in new and innovative ways
  • You enjoy solving problems and making a difference
  • It is important you can pragmatically balance quality with a fast-paced schedule
  • You are a good team player, ready to help, debate, compromise and work together
  • You are comfortable working, prototyping and delivering incrementally, adapting based on customer needs and technical difficulties, always with the user in mind
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