Quality Systems Manager

Touch Surgery ,
London, Greater London
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Overview

Job Description

5 billion people, two-thirds of the worlds population, do not have access to safe and affordable surgical care. As a result, millions go untreated every year causing unnecessary suffering, permanent debilitation, or death. This is all caused by a shortage of surgeons, varying quality of care, rising costs of training surgeons, lack of funding and lack of accessibility to quality surgery. Digital Surgery is on a mission to change this. With our award-winning Touch Surgery application and web platform, it is the dawn of Digital Surgery. Digital Surgery has created a digital data-driven ecosystem that uses cutting-edge technologies like AI, augmented reality and computer vision to modernise surgical training. In order to deliver the best possible products, Digital Surgery is looking for a Quality and Regulatory Affairs Manager. You will be responsible for all regulatory matters across Digital Surgerys product portfolio and for ensuring the companys quality processes meet and where possible exceed their requirements. As a QARA Manager here you will: * Implement and maintain an ISO13485:2016 compliant QMS for software and hardware projects * Support product development teams on regulatory issues, including writing and reviewing documentation and providing guidance and training for the company. * Oversee the development of the companys regulatory strategy for pre-market applications and related submissions for US, EU and Canadian markets. * Coordinate internal and external quality audits. * Promote a culture of compliance with regulations, standards, procedures and risk management policies. * Identify, develop and implement processes to support compliance activities related to post market surveillance, including complaint management, vigilance reporting and field actions. * Ensure all existing regulatory approvals/clearances are maintained appropriately and any product, system, software or other changes are appropriately reported and/or submitted for the appropriate approval, clearance or notification, as appropriate. Requirements Must-haves * Good communication and a pragmatic approach. * Experience in technical/procedure writing. * Experience working as a quality professional in the medical device regulatory environment. * Experience implementing and managing an enterprise-wide Quality System: ISO 13485. * Knowledge of CGMP requirements for FDA 21 CFR 820, EU Directive 93/42/EEC (as amended) and (EU) 2017/745 MDR. * Knowledge of international information security/privacy requirements (GDPR, ISO27001, HIPAA etc). * Knowledge of software life cycle management (IEC 62304). Nice-to-haves * Knowledge of hardware-related standards (LVD, FCC, RED, ROHS, WEEE, REACH) * Experience securing approvals for software as a medical device (SaMD). * Project Management experience. * Demonstrated interpersonal skills required to interface with technical and non-technical personnel at all levels of the organization. * A 'hands-on' individual who enjoys the challenge, is capable and dedicated to getting the job done. * Someone that has the ability to influence key stakeholders. * Experience acting as a lead auditor would be advantageous. Benefits Were in a really lucky position to operate like a small team, with all of the benefits of a big company. Following our acquisition by Medtronic in February 2020, our benefits have had an impressive face lift. ; Our benefit package aims to help support your health, build wealth, grow in your career and share in the success of Digital Surgery and Medtronic. We are in the healthcare business and so in order to look after our people we provide: * Private healthcare via AXA PPP - 100 excess * 30 days holiday + 8 bank holidays * Pension scheme (we double your personal contribution of up to 6%, by contributing 12%) * Annual bonus scheme * Annual meal allowance * Life insurance (4 x annual salary*) * Group Income Protection (67% of insured salary payable until pensionable age) * Personal Accident Cover ( 3 x annual salary) * Maternity - 20 weeks full pay + 15% returners bonus * Paternity - 2 weeks full pay * Employee Assistance Programme (support line for counselling, legal or financial advice) Not to mention all of the other bells and whistles such as free daily breakfast, employee recognition programs, cash for referring a friend and a whole host of other wellness benefits. As part of being Family Friendly, we encourage flexible working so you choose when you start and finish. Slack is one of our collaboration tools to help share information on what our teams are doing. You could even join the #coffee_buddies Slack channel to be matched up with someone for a face to face coffee. So whats it like working at Digital Surgery? Part of the Medtronic family we benefit from a small company feel, within the world's leading medical device company. We have 130 people globally, with teams across the UK, US and Canada. The majority are based in our London HQ in Old Street. The company is made up of several

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