Do you want to shape and contribute to the future of healthcare? Siemens Healthineers are looking for a Regulatory Technical Specialist to join their Healthcare Diagnostics business. This role can be based from home in the UK or can be based at the well-established and modern facility in Llanberis, located next to Snowdonia National Park. The facility manufactures and distributes reagents for in-vitro diagnostic medical devices used in hospitals worldwide to aid the diagnosis of medical conditions.
The primary function of this role is to provide Regulatory production support to the site and wider organisation to maintain compliance with regulatory requirements and Siemens procedures. You will collaborate with internal and corporate functional teams, Regulatory Teams, Competent Authorities, U.S. FDA and external agencies.
- Provide Regulatory Production Support to the site and to Regulatory Affairs Supervisor / Manager.
- Provide regulatory assessments for design and process changes. Communicate changes to the regions as required and provide regulatory requirement feedback from the regions to the change teams.
- Work with Manufacturing and Technical Operations to identify and prepare regulatory submissions to report post-market product changes to Regulatory Authorities. Reporting includes FDA PMA Annual Reports, FDA PMA 30-day notices or other supplements, 510(k) notes to file, 510(k) submissions, Notified body Annex II notifications, notification in line with IVDR requirements, other notifications other notifications.
- Provide regulatory support to Regulatory Affairs Supervisor / Manager with regards to CE and Annex 2 List B, product registration and registration in line with IVDR requirements
- Support Rest of World registration as required.
What do I need to qualify for the role?
- BS degree in scientific discipline
- Experience in the in vitro diagnostics industry
- Experience of working in a GMP environment
- Knowledge of compliance with key international standards i.e. ISO 13485, FDA regulations, European Directives and a working knowledge of regulatory requirements worldwide.
- Great attention to detail and communication skills
Being part of our team:
In Llanberis, Siemens Healthineers is the sole manufacturer of IMMULITE reagents, used in IMMULITE blood analysers to aid the diagnoses and treatment for patients – more information can be found here.
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.
· A competitive salary
· Generous pension contributions
· 26 days holiday
· 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 Diagnostics Products Ltd
Experience Level: not defined
Job Type: Full-time