1 FTE will be hired in South Africa, 1 FTE in UAE, and 1 FTE in Japan
Only candidates with valid work permits living in South Africa, UAE, or Japan will be considered for this role
This is a fixed term opportunity that will be until end of December 2023
We are targeting Specialist to Manager level profiles
Depending on the level, the official job title for this role will be iPDM Specialist/Manager Commercial Q&R IMEA and Asia .
SummaryWe aim to further shape and advance the way diabetes is treated by leveraging our integrated Personalised Diabetes Management approach (iPDM) - a holistic, patient-centric concept to diabetes management that includes connected devices, services, and digital solutions in an open ecosystem which will contribute to limiting the progression of the disease, and improving outcomes thus eventually promoting healthcare system sustainability.In order to do so, we are continuously refining our internal structures and processes to best serve evolving customer and market demand in a seamless and agile way. This enables us to deliver on our commitment to augment access to the most innovative iPDM solutions tailored to the needs of people with diabetes, their caregivers, and healthcare systems - today and in the future.As Quality & Regulatory Affairs Specialist/Manager, you will play a key role in implementing relevant aspects of the commercial Q&R strategy and thereby contribute to the overall Diabetes Care Vision at Roche.Job FactsThis position along with the associated Commercial Q&R organization is newly created as a result of the iPDM Target Operating Model program and will be responsible for Quality & Regulatory-related aspects within our commercial areas in IMEA & ASIA with focus on specific countries.Your Responsibilities
You are responsible to support the implementation and continuous improvement of the global commercial Q&R strategy in IMEA & ASIA regions, with a focus on assigned countries
You will build effective relationships with country organizations in- and outside of your country chapter with a special focus on proactive communication and enabling quality-related solutions
You are responsible for performing and supporting Q&R processes in your assigned country and beyond, incl. working in communities of practices and squads, as required
You contribute to the setup of your country chapter as a business enabling function supporting the business in all Q&R-related matters, in particular in regards to local Q&R compliance status, timely product registration according to approved launch plans, business challenges that need support from Q&R
You are responsible for local product registration activities, including creation of required documentation and interface to local authorities in close collaboration with our global DC Registration area
You serve as a point of contact and escalation body for all Q&R-related activities in assigned countries and beyond
You participate in network activities and proactively share best practices and learnings with the goal to further improve the Q&R landscape in and across country chapters
You act as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions by consistent business behavior that complies with applicable laws, industry codes and Roche?s Code of Conduct
Who You AreWe are looking for a passionate and decisive person. You demonstrate energy, passion, courage, vision and the drive to be part of an organization at the forefront of the industry, delivering benefits for patients, our people, and our business. Moreover, you bring the following:
You have an academic degree or comparable education. Academic degree in engineering or natural science or Life Sciences, Medical, Business or related discipline preferred
You have between 2 to 7 years of proven work experience in Quality and Regulatory Affairs in regulated industries, ideally in Medical Device industry.Practical experience with local regulations in particular countries will be an advantage
You are experienced with new ways of working (e.g. Agile) and process management tools (e.g. Lean Management)
You are energetic to drive change and find solutions quickly and effectively, taking into account the impact to other teams cross-functionally
You demonstrate the ability to build networks across country borders and you inspire agile working
You serve as advocate for the Roche Operating Principles which are: put patients first; follow the science; act as one team; embrace differences; accelerate learning; simplify radically; make impact now; think long term
You have a strong track record in prioritizing and simultaneously managing multiple projects (activities) in a fast paced environment for timely completion of projects
You bring the ability to manage key stakeholders
You are able to interact with peer groups and respond to questions in a manner consistent with professional etiquette
In addition to your native language, you have good English communication skills (oral and written)
Who We AreDoing now what patients need next. As pioneer in the development of blood glucose monitoring and insulin delivery systems, Roche Diabetes Care is committed to helping people with diabetes everywhere in the world think less about their daily diabetes routine, so they can get true relief, day and night.We offer a broad portfolio of solutions for both people with diabetes and their professionals - from blood glucose monitoring to information management to insulin delivery to continuous glucose monitoring. Our aim is to offer innovative products, services and comprehensive solutions for convenient, efficient and effective diabetes management.We are strongly committed to a diverse and inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing diversity enables us to create a great place to work and to innovate for patients.#LI-SH2Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we?ve become one of the world?s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Roche is an Equal Opportunity Employer.
