Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.
Then come and join our global team as Quality/ Regulatory Affairs Manager (f/m/d) for X-ray products to take on the role of quality representative of Siemens Healthineers’ Accessory Solution (AS) business, including process, regulatory and quality aspects. In that role, you are the quality partner for our Accessory Solutions department within the Business Line X-ray Products (XP) ensuring its global business success by effective, regulatory compliant implementation of all relevant standards and laws.
Your tasks and responsibilities:
- You will collect and provide quality & regulatory inputs relevant for the Accessory Solutions (AS) business
- You will interact with a variety of internal functions (e.g. marketing & sales, product life cycle management, procurement, price book, supply chain management) and external partners to ensure the proper qualification of 3rd party accessory suppliers as well as qualification of accessories for the target markets/ countries.
- You will maintain efficient and effective processes to enable AS business, including e.g. supplier onboarding process, regulatory country releases of accessories, combination of products, etc.
- You will implement regulatory requirements/ obligations (e.g. under MDR) for a distributor/ importer to protect AS business from a regulatory compliance perspective
- You will take responsibility of country approval tasks, including regulatory submissions, approval maintenance and development of approval strategy
To find out more about the specific business, have a look at Accessory Solutions.
Your qualifications and experience:
- You hold a university degree in engineering, medicine, biology or a comparable field of study
- You have long-term professional experience in quality management or regulatory affairs, or in a comparable position in the medical device industry, preferably with relevant knowledge of 3rd party accessories
- Good knowledge of regulations, standards and laws in the medical device arena (ISO 13485, 21 CFR 820, EU Medical Device Regulation)
- Knowledge and practical experience of 3rd party supplier quality management including distributor/importer’s obligations would be a plus
Your attributes and skills:
- You are fluent in English and German and able to communicate in those languages with internal stakeholders as well as with international suppliers
- On a personal level, your profile is rounded off by decision-making skills, the ability to analyze complex issues and the structured, reliable and goal-oriented handling of tasks
- You do not compromise on quality, while you fully understand the business and come up with practical, effective and efficient solutions. You will coordinate complex discussions with different stakeholders, and drive for a well-balanced decision between regulatory compliance and business impact
- Capability to utilize IT tools to automize and simplify complex processes is a plus
Our global team:
Siemens Healthineers is a leading global medical technology company. 65,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. 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.
Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success.
Check our Careers Site at https://www.siemens-healthineers.com/de/careers
As an equal opportunity employer, we welcome applications from individuals with disabilities.
Wish to find out more before applying? Contact us: +49 (9131) / 17 – 1717, if you wish to discuss any initial questions with our recruitment team. The contact person handling this job ad is Marlena Maier.
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Siemens Healthineers Germany was awarded the Great Place to Work® certificate.
Organization: Siemens Healthineers
Company: Siemens Healthcare GmbH
Experience Level: Experienced Professional
Job Type: Full-time