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We’re here to deliver better outcomes to more patients, faster.
That means the world to us.
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. The industry is never going to stand still.
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.
So, we’re shooting for the stars, transforming ourselves into a much more open, dynamic, transparent, inclusive, collaborative and agile business.
Our Commitments:
“Better outcomes to more patients, faster.”
* 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
… we ensure brilliance across the organisation
… we can feel brave, innovate and take calculated risks within legal and ethical fearing consequences if things “go wrong”
… we can bring our authentic selves to work
… we do not need permission. We take personal accountability and trust each other.
… we can develop our career based on our passion, experience & behavior and play to our strengths … we work within less hierarchy – and with more coaching
… everyone can be a leader, regardless of role
… we aim to spend 20% of our time on personal development
Our UK operating model is based on the following principles:
* Flexible resourcing across fit-for-purpose teams to address specific needs and priorities
* Healthcare-driven focus through outcomes
* Consultation, individual empowerment & accelerated decision-making through decentralisation
* Customer focus through mutually beneficial partnerships
Mindset and behaviour are 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.
We offer a starting point for you to consider and to reflect on what this might mean for you: we’re building a culture that is centered around growth mindset, prioritisation, ownership and accountability. We need individuals who are courageously authentic in their thinking and actions. This is what excites us about our future.
We believe that ongoing personal transformation is at the heart of organizational transformation and that knowing yourself is fundamental. Knowing yourself means understanding your strengths and weaknesses, passions and fears, desires and dreams, thoughts and feelings, likes and dislikes, tolerance and limitations. It requires you to: regularly stop, pause, and reflect as you change and develop, invite and share feedback, and know where to focus your development, when to hold things lightly and what to let go of. Knowing yourself means knowing your purpose and what fulfills you, enabling you to be authentic and bring your whole self to work.
Regulatory Partner Expectations:
The Regulatory group works with the wider business to translate the evolving UK Regulatory requirements 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 support the delivery of our innovative first-in-class combined drug/device portfolio. You will play a critical role in contributing to our strategic objectives in building this capability within the UK Pharma regulatory team and establishing strong internal and external networks to shape the regulatory environment.
The activities of this Partner encompass:
* Provide regulatory expertise on new product development and submission planning to project teams to ensure optimal time to approval and compliance in the lifecycle maintenance.
* Drive and support MHRA interactions concerning combination and/or medical device product submission strategies.
Ensure regulatory requirements are met for Clinical Trial Applications involving Medical Devices of any nature—physical devices, digital devices, in-vitro diagnostics, etc.
Support the maintenance of regulatory files and tracking databases for prompt and accurate access to regulatory information.
Support the implementation/adaptation of the medical device structure across the UK Affiliate.
Assist in external regulatory audits, providing input to minimize non-compliance findings.
Advise manufacturers/global teams on obtaining and maintaining UKCA marks and other regulatory milestones.
Monitor changes in UK Regulatory environment and assess impacts on current frameworks or new regulations. Participate in trade associations working groups and gather regulatory intelligence.
Provide training, mentorship, and coaching on medical device regulation as needed.
Review product and process documentation for compliance, monitor renewals, and assess changes to existing products and practices.
Review marketing materials and advise commercial teams accordingly.
Who you are:
You have a good understanding of the medical devices industry (desirable pharmaceutical/biotech experience) and experience working within a regulated environment. You seek greater depth in medical devices and regulatory strategies within pharma, with the ability to understand scientific and technical information relating to Roche products.
You have a strong track record in matrix teams and a passion for problem solving, contributing to or leading innovative solutions for complex regulatory issues. You have experience developing or contributing to product-level plans and hold a scientific degree. Please apply with your CV and cover letter. Good luck! Note: this role does not offer relocation or sponsorship support.
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