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Regulatory Affairs & Quality Specialist, home bw, homeworking and teleworking, united kingdom

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Client:

Siemens Healthcare Diagnostics Products Ltd

Location:

home bw, homeworking and teleworking, united kingdom, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

e171d1bafa7b

Job Views:

5

Posted:

12.05.2025

Expiry Date:

26.06.2025

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Job Description:

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Join our team now at Siemens Healthineers as a Regulatory Affairs & Quality Specialist and you will be working within the European Authorised Representative team supporting the EU Authorised Representative Manager.

Job Responsibilities:

• You will work closely with the team to ensure compliance with the following regulatory requirements:
• IVD Directive 98/79/EC
• IVD Regulation 2017/746
• RoHS Directive 2011/65/EU
• Medical Device Regulation 2002 (SI 2002 No 618)
• You will also work closely with other departments providing regulatory / quality support and guidance.
• Contribute to process improvements while ensuring regulatory compliance.
• Promote excellence and embrace right first time culture.
• Must be able to work independently when required, ensuring compliance to local and global procedures / processes.

Your Skills & Experience:

• A formal qualification, degree level or equivalent, in Regulatory Affairs or Quality management, or,
• Minimum 2 years experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.
• Excellent interpersonal and organisational skills.
• Must be a confident and organised communicator (verbal and written).
• Must work efficiently and be self-disciplined.
• Must be understanding, where necessary, recognise and respect views from others.
• Good IT skills, specifically Microsoft Office (including Outlook, Excel, Word, SharePoint etc.).
• 26 days' holiday with the option to buy or sell an additional 5
• Up to 10% employer pension contribution
• Share and 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 and support from our 24/7 employee assistance programme

Who we are:
We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

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. Siemens Healthineers are proud to be a Disability Confident Committed employer. If you require any adjustments at any stage of the recruitment process, please let us know.

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.