Regulatory Affairs & Quality Specialist

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. 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 regulatory requirements such as:
• IVD Directive 98/79/EC
• IVD Regulation 2017/746
• RoHS Directive 2011/65/EU
• Medical Device Regulation 2002 (SI 2002 No 618)
• Collaborate with other departments to provide regulatory and quality support and guidance.
• Contribute to process improvements while ensuring regulatory compliance.
• Promote excellence and embrace a right-first-time culture.
• Work independently when required, ensuring compliance with local and global procedures and processes.

Your Skills & Experience:

• A formal qualification, degree level or equivalent, in Regulatory Affairs or Quality Management, or related field.
• Minimum 2 years of experience in regulatory affairs or quality management systems related to in vitro diagnostic medical devices.
• Excellent interpersonal and organizational skills.
• Confident and organized communicator (verbal and written).
• Efficient, self-disciplined, and respectful of others' views.
• Good IT skills, specifically Microsoft Office (Outlook, Excel, Word, SharePoint, etc.).

Our Benefits:

• 26 days' holiday with the option to buy or sell an additional 5 days.
• Up to 10% employer pension contribution.
• Share and bonus scheme.
• Access to flexible benefits, including private medical insurance and dental cover.
• Corporate Social Responsibility opportunities, including 2 paid volunteering days per year and support from our 24/7 employee assistance program.

Who we are:

We are a team of over 71,000 dedicated Healthineers across more than 70 countries. As leaders in medical technology, we aim to create better outcomes and experiences for patients worldwide. Our portfolio supports clinical decision-making and treatment pathways.

How we work:

Joining Siemens Healthineers means becoming part of a global team of scientists, clinicians, developers, researchers, and professionals from diverse backgrounds. We believe in each individual's potential and work together to fight diseases and improve access to care, united by the purpose to pioneer healthcare breakthroughs for everyone, everywhere, sustainably.

We are an equal opportunity employer and welcome applications from individuals with disabilities. If you need adjustments during the recruitment process, please let us know.

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To all recruitment agencies:

Our recruitment is managed internally, and external support is only permitted through qualified suppliers with a formal contract. Unsolicited submissions are not accepted and will be deleted. We appreciate your understanding and adherence to our policies.