Overview

Regulatory Affairs & Quality Specialist - Home Based - FIXED TERM CONTRACT UNTIL END OF DECEMBER 2026

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.

Siemens Healthineers is looking for a full-time Regulatory Affairs Specialist on a Fixed Term Contract basis until the end of 2026 to cover a period of maternity leave, offering a competitive salary and benefits package and the opportunity to further build your experience in a leading organisation.

Your Role

• In relation to OUS Field Actions for the Diagnostics Business Line, liaise with legal Manufacturers and country Quality Teams, provide reporting recommendation, review approve and distribute documents.
• Provide Diagnostics Quality with feedback / questions and ensure closure for each Field Action.
• Where applicable, complete reporting activities in accordance with IVDR Article 87(7) and UK MDR (Regulations 44ZJ and Regulation 44ZK).
• Coordinate OUS Field Action enquiries.
• Be a Point of Contact for EU AR / UK Responsible Person on behalf of the US & UK legal Manufacturers.

Your Experience

• Knowledge of compliance with key international standards (i.e. ISO 13485, FDA regulations, European Directives and Regulations) and regulatory requirements worldwide (preferable but not mandatory).
• Degree qualification in Regulatory Affairs or Quality discipline is desirable but not mandatory, or appropriate professional experience in regulatory affairs or quality management systems relating to in vitro diagnostic medical devices.
• Proven experience in a regulatory role, preferably in the in-vitro diagnostics industry; other medical devices backgrounds will be considered.
• Proficient in Microsoft Office (including Outlook, Excel, Word, SharePoint, etc).
• Promote excellence and embrace right first time culture with accuracy and attention to detail.
• Ability to work efficiently, be self-disciplined, and handle pressure with prioritisation when required.
• Dynamic team player with problem-solving skills, able to work independently and within a team.
• Good communicator fluent in English (speaking and writing) with strong organisational skills.

Benefits

• Competitive basic salary
• Up to 10% matched pension contributions
• BUPA Private Medical Cover
• Bonus
• Share Save Scheme
• 26 days annual leave (with the option to buy/sell up to 5) + bank holidays
• Range of additional salary sacrifice benefits including EV car scheme, global travel insurance and dental cover

How we work

When you join Siemens Healthineers, you become part of a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

As an equal opportunity employer, we welcome applications from individuals with disabilities. We care about your data privacy and take compliance with GDPR and other data protection legislation seriously. For this reason, please create a profile within our talent community and subscribe to personalized job alerts that will keep you posted about new opportunities.

To all recruitment agencies: Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete unsolicited information.