Head of Regulatory Affairs

About ANGLE: ANGLE is a world-leading liquid biopsy company commercialising a patent protected platform technology that can capture rare circulating tumour cells (CTCs) from blood, in a minimally invasive way, for downstream analysis. ANGLE's Parsortix system is FDA cleared for its intended use in metastatic breast cancer and is currently the first and only FDA cleared medical device to harvest intact circulating cancer cells from blood. Parsortix technology comprises a microfluidic device that captures CTCs from blood based on their size and compressibility. CTCs are cancer cells that have detached from the primary tumour and entered the blood circulation, and they play a critical role in initiating metastasis. Once harvested, the CTCs can be comprehensively analysed to provide a wealth of information about the patients tumour, advancing cancer research and potentially personalized medicine. This technology has the potential to deliver profound improvements in clinical and health economic outcomes. ANGLE has established a CTC harvest and analysis service from our UK-based Clinical Laboratory based in Guildford for customers worldwide. In alignment with company priorities, we plan to rapidly expand our services to include molecular profiling of CTCs and ctDNA using digital PCR and NGS to add to our image-based assays. Join our Team: This is an exciting time at ANGLE and our team in Guildford are looking for a Head of Regulatory Affairs to act as the person responsible for regulatory compliance (PRRC) for MDR/IVDR and to provide a strategic direction and operational regulatory guidance to ensure the organisation complies with applicable regulations. At ANGLE, we foster a dynamic, entrepreneurial approach to translating leading-edge translational research into clinical diagnostics. We promote a culture of collaboration and shared excellence while encouraging an open and honest exchange of ideas. We are always in search of potential employees who share our vision and want to make a difference today. In your submission, please describe your background and what you can bring to our team along with attaching your resume. Principal Accountabilities: Acts as PRRC for MDR/IVDR Manages the regulatory and quality teams Responsible for department budget submission and monitoring Provide regulatory guidance to NPD projects, including: Define regulatory strategy and implement it to achieve desired project/programme goals Analytical and clinical verification/validation study scoping, design and phasing to ensure compliance with ISO standards Work with Clinical Study Manager to setup, initiate and monitor analytical and clinical verification and validation studies at 3rd party sites, including appropriate ethics (IRB) clearances and permissions, and SOPs for study conduct Provide guidance to the R&D teams in the deployment of NPD procedures specifically on regulatory matters, and in line with the Company ISO13485 and ISO15189 quality systems Manage and deliver post market surveillance activities for our IVD product(s) to meet regulatory requirements in territories where product(s) are registered Liaise with regulatory authorities and notified bodies and create device registration submissions in conjunction with in-territory advisors/distributors in support of ANGLE's global commercial rollout, including materials such as: Declarations, notarised documents and certificates Technical file data and device information Risk analyses and benefit-risk arguments Data collection and interpretation Verification and validation reports Interpretation of standards and guidance documents Labeling documents Keep up to date with current regulatory standards and requirements as relevant to ANGLE's desired areas and locations of business; and apply such knowledge to day to day activities Review product promotional material and all external content for regulatory compliance Proactively contribute and monitor the content of individual Design History Files in support of company New Product Development (NPD) procedures and regulatory requirements Drive the Company ISO13485 and ISO15189 quality systems in accordance with procedures, adapting the system as and when required Represent regulatory and quality functions in internal and external audits Support ANGLE Clinical Laboratory in securing and maintaining quality system accreditations Be prepared to regularly travel to ANGLE sites and 3rd party study sites in UK/Europe/North America which may necessitate overnight stays and short periods away from home. Adopt a flexible and collaborative approach to the requirements of the job Undertake additional ad-hoc tasks as required Qualifications, Experience, Knowledge and Attributes: Biomedical degree/PhD with extensive experience of IVD medical device product development adhering to standards such as ISO14971 is essential Previous experience of working in IVD assay development Excellent knowledge of global medical device directives and regulations, MEDDEV guidelines, ISO standards, US FDA and worldwide regulatory requirements Experience of developing regulatory pathways with a proven track record of approvals worldwide Comfortable with taking difficult and important decisions to maintain our regulatory compliance Detail oriented with a commitment to high quality documents and data Ability to work on multiple projects simultaneously and to a high standard A flexible, can-do approach to the requirements of the job. Job Requirements: Due to the nature of the role, our requirement is for this position to be Guildford-based, with some flexibility to work from home at the discretion of the Manager. As a member of our highly skilled team you will receive opportunities for training and development and a competitive benefits package. Please let us know if you require disability-related accommodation during the recruitment process so that we can work with you to meet your needs. Furthermore, please be advised that if you submit an application to us for this position, your application and personal details will be processed in accordance with our Data Privacy Notice for Job Candidates.

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