Safety Officer & Regulatory Specialist - FTC Maternity Cover
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 travel
About 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