Regulatory Affairs

3 weeks ago

Birmingham, United Kingdom Siemens Healthineers Full time

**Now’s our time to inspire the future of healthcare together.** Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 66,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.

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 support to the European Authorised Representative (EU AR) team on a day to day basis. This role reports to and supports the EU Authorised Representative Manager to ensure compliance to the requirements of IVDR Regulation (EU) 2017/746, UK regulation (MDR 2002), as well as other relevant global regulatory framework. This team works closely with other departments providing regulatory/ quality support in a manner that is consistent with the company's Business Principles.

In this role, you can expect to:

- Be responsible for day to day EU AR Team input into complaint handling tool
- In relation to Manufacturer Incident Reporting (MIR) in UK & EU countries, liaise with legal Manufacturers and country Quality Teams, provide reporting recommendation, review and approve reports, ensure on time processing and filing with National Competent Authorities
- Co-ordinate the EU AR Team MIR enquiries
- Be a Point of Contact for EU AR / UK Responsible Person on behalf of the US & UK legal Manufacturers

You will also require the following:

- Degree qualification in a relevant discipline (Regulatory Affairs or Quality degree is desirable but not mandatory) and/or appropriate professional experience gained working in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.
- Proficient in Microsoft Office (including Outlook, Excel, Word, SharePoint, etc)
- Promote excellence and embrace right first time culture. A strong understanding of the need for accuracy
- Work efficiently and be self-disciplined
- To work well under pressure and to be able to identify the need to prioritise when required
- To be a dynamic team player who displays problem solving skills, who can work effectively and proactively on activities both individually and within a team
- Good communicator fluent in English in both speaking and writing with strong organisational skills

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