Descrizione del lavoro:
Are you passionate about medical device regulations and ensuring these meet with global compliance guidelines? Do you have a background in maintaining medical device Quality Management Systems (QMS) and improving procedures and processes associated with this?
We are seeking a Medical Device Quality and Regulatory Manager to be responsible for "Regulatory Compliance" and act as the QMS Management Representative for Babylon. You will monitor documentation and metrics and keep evidence of compliance, alongside leading internal and external audits. You will also provide appropriate global and local regulatory strategy, submissions and communication internally, as well as with Regulators, Notified Body and EU Authorised Representatives.
WHAT YOU'LL WORK ON
* Provides medical device regulatory strategy for the company globally
* Acts as Management Representative for the EN ISO xxxx5:2016 Quality Management System.
* Ensures that all Babylon Quality processes are documented, trained and managed in the organisation.
* Supports the development of a Global Quality Management Strategy/System.
* Represents and escalates Regulatory & Quality issues on various Committees and Boards within the company, including the Management Review
* Validates internal and external commercial off the shelf (COTS) support services used in Babylon's medical devices
* Supports and, where appropriate, validates Software Of Unknown Provenance (SOUP)
* Leads or participates in internal and external audits, maintaining oversight of medical device audit activities
* Looks after a medical device within the Babylon portfolio of products, maintaining the device history file and the technical file for that product
* Supports crucial regulatory interactions and communications with Regulators, Notified Bodies and other authorities
* Carries out regulatory and quality tasks for (COMPANY NAME) Ireland Ltd as appropriate
* Acts as the deputy Person Responsible for Regulatory Compliance (PRRC) for Babylon Partners Ltd
WHAT WE'RE LOOKING FOR
* 5 years' + of experience in the medical device industry with at least 3 of these working in a Regulatory & Quality department or equivalent consulting position
* At least 2 years audit experience
* Experience with EU, UK and US markets
* Understanding of European & UK Quality requirements, including standards (ISO xxxx5:2016)
* Understanding of European requirements laid out in the MDR, in order to appropriately act as the Person Responsible for Regulatory Compliance
* Experience in software development would be advantageous, as would Lead Auditor experience
WHAT WE OFFER
* Competitive salary package
* New Hire Company Stock Grants (RSU)
* Refresh Company Stock Grants (RSU)
* Unlimited PTO
* Flexible working hours and remote working.
* Private health care including physio and wellbeing for you, your partner and children
* Life insurance cover of 4x salary
* Pension contribution matched up to 5%
* The Babylon App! Gain access to unlimited free consultations for you and your nearest and dearest.
WORKING AT BABYLON
Whether you work in one of our amazing offices or a distributed team, Babylon is highly collaborative and fun! You'll have a chance to work in a fast-paced environment with experienced industry leaders. We have a learning environment where you can make an impact.
WHO WE ARE
We are a team on a mission, to put accessible and affordable healthcare in the hands of every person on earth. Our mission is bold and ambitious, and it's one that's shared by our team who shares our values, to dream big, build fast and be brilliant. To achieve this, we've brought together one of the largest teams of scientists, clinicians, mathematicians and engineers to focus on combining the ever-growing computing power of machines, with the best medical expertise of humans, to create a comprehensive, immediate and personalized health service and make it universally available.
At Babylon our people aren't just part of a team, they're part of something bigger. We're a vibrant community of creative thinkers and doers, forging the way for a new generation of healthcare. We're only as good as our people. So, finding the best people is everything to us. We serve millions, but we choose our people one at a time…
DIVERSITY AT BABYLON
We believe that difference inspires a better, healthier world. That's why it's at the heart of everything we do. From our people to our products, difference enriches every part of our business and creates a culture based on equality of opportunity, and in which all Babylonians can progress their careers. We're committed to creating an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, colour, religion, sex, pregnancy status, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, and any other characteristic protected by applicable law
|Pubblicato il:||03 Dic 2022|
|Durata di lavoro:||24 mesi|