Regulatory Partner

Social network you want to login/join with: We’re here to deliver better outcomes to more patients, faster. Our achievements help to transform the lives of millions of people. We’ve been supporting patients for over 125 years in the UK, building a reputation that we’re intensely proud of. Through this success, we’ve set an incredibly high standard. Those expectations continue to grow. The environment in which we operate changes at an ever-increasing pace. As one united team at Roche UK, we know we need to boldly respond to these changes whilst keeping our customers and our patients at the heart of everything we do. Our Commitments: Healthcare partners are ‘wowed’ when they work with us Our innovations are faster and bolder We provide services and products to better serve people Purpose is our primary motivator We spend our time contributing where it adds the most value Mindset and behaviour is as important to us as experience and capabilities. We won’t tell you how to behave with detailed competency frameworks; we ask you to bring your differences so we can celebrate a more diverse and inclusive workforce. Regulatory Partner Expectations: The Regulatory group works with the wider business to translate the constantly evolving requirements of the UK Regulatory environment into Roche policies, procedures, solutions and strategies that ensure compliance and maximum value to patients. As a Regulatory Partner with a medical devices background, you will be focussed on supporting the delivery of our broad and innovative first in class combined drug/device portfolio. The activities of this Partner encompass: Provide regulatory expertise on new product development and submission planning to project teams (Squads, Work Packages, etc.) to ensure optimal time to approval and continued regulatory compliance in maintenance of the lifecycle. Drive and support MHRA interactions that concern combination and/or medical device product submission strategy Ensure that regulatory requirements are met for Clinical Trial Applications that involve Medical Devices of any nature (physical devices, digital devices, in-vitro diagnostics, etc.) Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information Provide support for the implementation/adaptation of the medical device structure across the UK Affiliate Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance Advise the manufacturers/global team to obtain and maintain a UKCA mark and/or any relevant regulatory milestone that concern the UK Continuously monitor the changes to the UK Regulatory environment and provide an impact assessment on changes to the current framework and/or implementation of new Regulations Be part of Trade Associations (ABPI, MedTech, etc.) working groups and gather regulatory intelligence Provide training/mentorship and/or coaching support as required on medical device regulation and all its related aspects Assist in reviewing product and process documentation for assigned projects to ensure compliance with requirements, as well as monitor renewals to strict deadlines Assess changes to existing products and company practices and provide an impact assessment, where necessary Review Marketing materials and provide advice to the commercial teams on business-related activities Who you are: With a good understanding of the medical devices industry (desirable pharmaceutical/biotech industry) and experience working within a regulated environment, you are in pursuit of seeking greater depth and exposure to medical devices and combination regulatory strategies within the pharma sector. You will hold a scientific degree. Please apply with a copy of your

CV and a cover letter.

Good luck with your application! This role unfortunately does not offer relocation or sponsorship support. Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.

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