European Authorised Representative Assistant – Home Working
Do you want to contribute to the future of healthcare? Siemens Healthineers are looking for a European Authorised Representative Assistant to join our team. Reporting to the EU Authorised Representative Manager, the position will work with and support three Regulatory Affairs and Quality Specialists. The team works remotely and the role is open to either home working or the possibility to work in one of sites in Camberley, Sudbury, Llanberis or Oxford. There will be a requirement to travel for quarterly team meetings.
Siemens Healthineers are one of the world's largest suppliers to the healthcare industry and a pioneer in affordable and personalised healthcare. We are inspired to transform the way things are done – because we want what is best for our people, our customers, and ultimately to help everyone live longer and healthier lives. To find out more about our business and recent news, including our continued response to COVID-19, please explore our website.
Your mission and responsibilities:
- Assisting in the filing of Field Safety Corrective Action (FSCA) Reports and Medical Device Vigilance Reports (MDVR) to EU National Competent Authorities (NCA) as and when required.
- Update EU AR Report with all FSCAs and MDVRs issued by EU AR Team on a monthly basis
- Update EU AR Report with all National Compentent Authority Reports (NCAR) received by EU AR Team on a monthly basis
- Provide monthly reporting metrics to EU AR Manager (new) EU & UK registrations / (new) Product Change Notifications (PCN) / Free Sale Certificate's (FSC) submitted / CE & UK Releases
- Management of Outlook / Shared Drive organisation
- reminders on a daily basis
- Review all open FSCAs and send email reminders to primary / secondary contacts on a weekly basis
- Maintain contact lists in SharePoint as required
- Issue FSCA Additional Customer Lists as directed by the legal Manufacturers
- Involvement in audit preparation & support
Your qualification and experience:
- Strong organisational skills with the ability to plan and prioritise workload
- Deliver work to a high standard and to agreed deadlines
- Strong interpersonal skills with the ability to communicate confidently with stakeholders across all levels
- The ability to take ownership and accountability for day-to-day responsibilities
- Highly motivated, team player, enjoys working with colleagues potentially from within a multinational and multicultural environment
- Proficient with Microsoft Office and email systems
- A passion and interest for working in healthcare
Being part of our team:
Siemens Healthineers is a leading medical technology company with a 170-year legacy of first-to-market technologies and product innovations. Passionately driven by empowering healthcare providers to better help their patients, our technologies touch an estimated 5 million patients globally every day. We are committed to helping healthcare providers to succeed and work in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine as well as digital health and enterprise services.
- A competitive salary
- Generous pension contributions
- 26 days holiday
- On-site gym and subsidised restaurant
- Access to our flexible benefits from private medical insurance to dental cover
- Corporate Social Responsibility opportunities including 2 paid volunteering days per year
- Support from our 24/7 employee assistance programme
In addition, we provide a flexible and dynamic environment with the space to stretch beyond your comfort zone in order to grow both personally and professionally. Our unique team spirit arises from embracing different perspectives, open debate, and the will to challenge conventions. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we want you to seek, implement and celebrate your best ideas.
We recognise that building a diverse workforce is critical to the success of our business. We strongly encourage applications from a diverse talent pool and welcome the opportunity to discuss flexibility requirements with our applicants to encourage agile working.
Organization: Siemens Healthineers
Company: Siemens Healthcare Limited
Experience Level: not defined
Job Type: Full-time