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For Companies At a Glance
- Tasks: Coordinate regulatory affairs and quality management for diagnostic medical devices.
- Company: Siemens Healthineers, a global leader in medical technology.
- Benefits: Competitive salary, private medical cover, generous leave, and pension contributions.
- Why this job: Join a dynamic team making a real impact in healthcare innovation.
- Qualifications: Experience in regulatory affairs or quality management preferred; degree desirable but not mandatory.
- Other info: Work remotely with a diverse team dedicated to pioneering healthcare breakthroughs.
The predicted salary is between 36000 - 60000 £ per year.
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.
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Regulatory Affairs & Quality Specialist employer: Siemens
Contact Detail:
Siemens Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs & Quality Specialist
✨Tip Number 1
Network like a pro! Reach out to folks in the regulatory affairs and quality sectors on LinkedIn. Join relevant groups and engage in discussions. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by researching Siemens Healthineers thoroughly. Understand their products, values, and recent news. This will help you tailor your answers and show that you're genuinely interested in being part of their team.
✨Tip Number 3
Practice common interview questions related to regulatory affairs and quality management. Think about your past experiences and how they relate to the role. We can even help you with mock interviews if you need a bit of extra practice!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, you can set up job alerts to stay updated on new opportunities that match your skills.
We think you need these skills to ace Regulatory Affairs & Quality Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs & Quality Specialist role. Highlight relevant experience and skills that match the job description, especially your knowledge of compliance and regulatory requirements.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about healthcare and how your background makes you a great fit for Siemens Healthineers. Don’t forget to mention any specific experiences related to in-vitro diagnostics.
Showcase Your Attention to Detail: In regulatory affairs, attention to detail is key. Make sure your application is free from typos and errors. This not only reflects your professionalism but also your ability to maintain high standards in your work.
Apply Through Our Website: We encourage you to apply through our website for the best chance of being noticed. It’s straightforward and ensures your application goes directly to our recruitment team. Plus, you can set up alerts for future opportunities!
How to prepare for a job interview at Siemens
✨Know Your Regulations
Make sure you brush up on key international standards like ISO 13485 and FDA regulations. Being able to discuss these confidently will show that you understand the regulatory landscape, which is crucial for a Regulatory Affairs & Quality Specialist.
✨Showcase Your Experience
Prepare specific examples from your past roles that highlight your experience in regulatory affairs or quality management systems. Tailor your stories to demonstrate how you've handled compliance issues or field actions in the past.
✨Be Detail-Oriented
Since attention to detail is vital in this role, be ready to discuss how you ensure accuracy in your work. You might want to share methods you use to double-check your reports or documents before submission.
✨Communicate Effectively
Practice articulating your thoughts clearly and concisely. As a point of contact for various teams, being a good communicator is essential. Consider doing mock interviews to refine your communication skills and get comfortable with potential questions.
