Safety Officer & Regulatory Specialist - FTC Maternity Cover
Imagine working for an organisation that focuses on putting people at the heart of what they do. Where every single person within the organisation is aligned to one main motivating force, that at the centre of everything they do, and their number one priority; are patients. A place that gives every individual the autonomy and empowerment to make a difference, where you are not defined by a job title. Imagine waking up every morning feeling fulfilled, having purpose and meaning in your work.
Imagine you are at Roche.
We are a pioneer in pharmaceuticals, advancing science to help people in the UK live longer and healthier lives. For over 120 years we have created truly differentiated medicines for cancer, the immune system, infectious diseases, ophthalmology and diseases of the central nervous system.
We work from bench to bedside - researching new medicines, running global clinical trials, and collaborating with the NHS to try to ensure rapid uptake and delivery of our products and services. Our drive, every day, is to ensure our medicines reach those who need them as soon as possible.
None of this would be possible without our extraordinary employees; our people make our business. We offer inspirational opportunities for employees that are as unique as they are. We have created an inclusive, respectful work environment where people can be authentic and truly invested in their work, a place to belong. Our outstanding commitment to workplace engagement has recently been recognised by our inclusion at number four on the Sunday Times Top 25 Best Big Companies to Work
The Disease Community Lead (DCL) is pivotal to the success of our customer facing teams and ultimately, ensuring patients have access to the best possible treatments for their disease. This strategic matrix management role will support, mentor and coach the “Regional Network” (a cross functional team in a given geographic area). Responsible for facilitating the compliant promotion of the Roche Portfolio products, within an assigned regional geography. The DCL role has responsibility for assisting in executing national brand strategy, assisting in the development of regional based strategy and delivering on performance goals.
The ability to inspire, motivate and coach this cross functional team will be crucial in this role. Helping the team create a clear strategic plan for the Region, combining Roche and NHS priorities that deliver not only on our commercial objectives, but also driving partnerships that deliver mutually beneficial outcomes.
The DCL position is field based, and ideally located within an assigned geographic region (North West).
At Roche Diabetes Care we have an exciting opportunity for a Safety Officer & Regulatory Specialist (FTC Maternity Cover) to join our team, reporting to the Compliance Officer & Business Sustainability Team Manager.
In this role, you will be responsible for ensuring that adequate processes are in place to monitor and contribute to the progress of all safety cases, including communications with regulatory authorities and customers whilst ensuring implementation of corrective and preventative actions.
To be successful in this role you will have a highly organised approach to your work with exceptional communication skills at all levels. You will successfully manage key relationships with internal parties, Safety Boards, GSS and business areas with respect to product safety.
The Safety Officer & Regulatory Specialist is responsible for:
- Ensure Roche Diabetes Care UK Ltd meets Medical Device Regulations.
- Product Registrations, Maintenance and Extension.
- Carry out when requested Medical Device Post Market Surveillance.
- Early identification & trending of Product Complaints.
- Maintaining Regulatory relationships with the external agencies.
- Management of key relationships with internal parties, Safety Boards, GSS, Business Areas with respect to product safety.
- Management of the communication of safety issues including company product bulletins and notices.
- Management of reporting of product quality issues impact Diabetes Care Ltd.
- Co-ordinate with the respective business areas to keep abreast of new/changes to products and process developments effecting safety.
- Ensure that there are adequate processes to monitor and contribute to the progress of all safety cases, including communications with the Regulatory Authorities, customers and implementation of corrective and preventative actions.
- Identify areas where regulatory & safety input is required for the transition to Services & Solutions.
- To prepare & carry out any activities required for BREXIT in relation to Regulatory & Safety.
The ideal candidate will have previous proven experience in regulatory operations and be self-motivated with a passion for achieving results. For this position, you will bring:
- University Degree in relevant subject area or equivalent
- Previous proven experience working in a similar role for an international company in Regulatory / Safety operations
- Proven experience working directly with registered bodies and the MHRA / HSE
- A highly organised approach with exceptional communication skills at all levels
- Demonstrated ability to influence and drive change
- A high sense of personal responsibility with proven ability to manage challenging priorities whilst meeting deadlines
- SAP experience would be advantageous
- Experience working with the Google suite of programmes
- Flexibility to travel – this role may require some travelAbout Roche Diabetes Care UK & Ireland
“Together, we are committed to improving health, today and tomorrow because it matters to us all. We are Roche Diabetes Care”
More than 5,500 employees in over 100 markets worldwide, work every day to support people with diabetes and those at risk to achieve more time in their target ranges and experience true relief from the daily therapy routines.
Being a global leader in integrated Personalised Diabetes Management (iPDM), Roche Diabetes Care collaborates with thought leaders around the globe, including people with diabetes, caregivers, healthcare providers and payers. Roche Diabetes Care aims to transform and advance care provision and foster sustainable care structures. Under the brands RocheDiabetes, Accu-Chek and mySugr, comprising glucose monitoring, insulin delivery systems and digital solutions, Roche Diabetes Care unites with its partners to create patient-centred value. By building and collaborating in an open ecosystem, connecting devices and digital solutions as well as contextualising relevant data points, Roche Diabetes Care enables deeper insights and a better understanding of the disease, leading to personalised and effective therapy adjustments. For better outcomes and true relief.
Roche Diabetes Care has been pioneering innovative diabetes technologies and services for more than 40 years. Our UK & Ireland team is a group of passionate and committed colleagues who embrace our culture to deliver the best outcomes for patients.
Managing increased complexity requires us as Diabetes Care to shift to an even more agile, adaptive and collaborative mindset.
We@RocheDiabetesCare describes the mindset, culture and behaviours we as Diabetes Care colleagues strive to adopt to help achieve our vision and realise our strategy.
Our five mindset dimensions help us on what is collectively important to us and provide examples of behaviours we would like to demonstrate:
- We are passionate about our customers and patients
- We radically simplify
- We trust, collaborate & have fun
- We ALL Lead
- We experiment & learn