Regulatory Affairs & Quality Specialist at Siemens

, , United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

19 Dec, 25

Salary

0.0

Posted On

20 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Quality Management, ISO 13485, FDA Regulations, European Directives, In Vitro Diagnostics, Problem Solving, Communication, Organizational Skills, Self-Discipline, Team Player, Accuracy, Microsoft Office, Field Actions, Compliance, Reporting

Industry

Automation Machinery Manufacturing

Description

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. Do you have regulatory experience, and are you seeking a new job? 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. 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. 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. To provide Diagnostics Quality with feedback / questions and ensure closure for each Field Action. Where applicable, to complete reporting activities in accordance with IVDR Article 87(7) and UK MDR (Regulations 44ZJ and Regulation 44ZK) Co-ordinate 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: To apply for this role, you will need knowledge of compliance with key international standards (i.e. ISO 13485, FDA regulations, European Directives and Regulations) and with regulatory requirements worldwide (preferable but not mandatory) 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. Proven experience in a regulatory role, preferably in the in-vitro diagnostics industry, although other medical devices background will also be considered 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 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 A range of additional salary sacrifice benefits including EV car scheme, global travel insurance and dental cover to name a few How we work: When you join Siemens Healthineers, you become one in 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 as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. Please create a profile within our talent community and subscribe to personalized job alert 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 and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.

Responsibilities

Provide regulatory support to the EU Authorised Representative team and ensure compliance with IVDR Regulation and UK regulations. Liaise with legal manufacturers and country quality teams regarding OUS Field Actions and coordinate inquiries.