Regulatory Affairs and Quality Specialist

Do you want to contribute to the future of healthcare? Come and join Siemens Healthineers as a Regulatory Affairs and Quality Specialist.

We have 2 roles available, 1 based in Ireland and 1 in the UK.  This is a homebased position.

Purpose of the role and responsibilities:

You will be working within the European Authorised Representative team supporting the EU Authorised Representative Manager.

You will work closely with the team to ensure compliance with the following standards:

IVD Directive 98/79/EC

IVD Regulation 2017/746

RoHS Directive 2011/65/EU

Medical Device Regulation 2002 (SI 2002 No 618)

(The standards we work towards differ depending on whether you are Ireland or UK based).

• You will also work closely with other departments providing regulatory / quality support and guidance.
• Contribute to process improvements while ensuring regulatory compliance

Qualifications & Experience:

Required experience is either:
(a) A formal qualification, degree level or equivalent, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices;
(b) Significant professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.

• Self-motivated with the ability to deliver a high standard of work within agreed deadlines.  Good time management and facilitation skills.
• Excellent interpersonal and organisational skills.  Must be able to work well within a team and display strong problem solving skills
• Strong communication skills - must be a confident and organised communicator (verbal and written). 
• Promotes excellence and embraces right first time culture.  A strong understanding of the need for accuracy.
• Must work efficiently and be self-disciplined.  Able to work well under pressure and to be able to identify the need to prioritise when required.
• Must be understanding, where necessary, recognise and respect views from others.
• Must be able to work independently when required ensuring compliance to local and global procedures / processes
• Good IT skills, specifically Microsoft Office (including Outlook, Excel, Word, SharePoint etc)

Being part of our team:

Siemens Healthineers is a leading global medical technology company. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. 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.

We offer a competitive salary, excellent pension contributions, 26 days holiday, private healthcare options and other flexible benefits.

Your cultural fit:

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 and innovation.