Regulatory Affairs Specialist - Home Based Do you have regulatory experience, and are you seeking a new job? Siemens Healthineers is looking for a full-time Regulatory Affairs Specialist, and the remote role comes with an attractive salary and benefits package. As a Regulatory Affairs Specialist, you will provide regulatory production support to the site and wider organisation to maintain compliance with regulatory requirements and Siemens procedures. You will also handle the regulatory assessment of design and process changes and deviations, reporting changes as required. In this role, you can expect to: Provide Regulatory Production Support to the site and to Regulatory Affairs Supervisor/Manager Support ROW registration as required Provide regulatory support for CE and Annex 2 List B, IVDR Class B,C,D, product registration Communicate changes to the regions as required and provide regulatory requirement feedback from the regions to the change teams. To apply for this role, you will need awareness of working in a GMP environment and knowledge of compliance with key international standards i.e. ISO 13485, FDA regulations, European Directives and Regulations and a working knowledge of regulatory requirements worldwide. You will also require the following: Degree qualification in a scientific discipline or equivalent experience and/or minimum 5 years of work experience, preferably in the in vitro diagnostics industry Understanding of computer software including Word, Excel and Access. To apply for this remote full-time Regulatory Affairs Specialist job, please contact Siemens Healthineers today. Please refer any friends or colleagues for this role or direct them to our Careers page on our website. We have great benefits including, 26 days holiday with the option to buy or sell an additional 5, up to 10% employer pension contribution, share scheme, bonus scheme, 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. We recognise that building a diverse workforce is critical to the success of our business. We encourage applications from a diverse talent pool and welcome the opportunity to discuss flexibility requirements with our applicants to encourage agile working. Siemens Healthineers are Great Place to Work Certified and a Top 100 Rate My Apprenticeship employer. Organization: Siemens Healthineers Company: Siemens Healthcare Diagnostics Products Ltd Experience Level: Experienced Professional Full / Part time: Full-time