Back

Lead Quality / Regulatory Affairs Manager

Job Description

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.

 

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting?

   

Then come and join our team as Software Quality Manager / Regulatory Affairs Manager for AI-based Software Products to ensure adherence of our customer service digital products with quality processes and standards.

   

Your tasks and responsibilities:

• In coordination with the regional units, you will draw up market access strategies and apply for licenses for AI-aided devices for the Digital Health (DH) business area

• You will ensure compliance (of software products) with legal and normative requirements, regulatory as well as with respective risk management results (including tailoring of processes as appropriate) 

• You will be responsible for coordinating, carrying out and documenting approval activities and for ensuring that the devices registered comply with the law

• You will be responsible for compliance with internal and external country-specific rules for the approval of medical devices

• You will provide support with the evaluation and approval of product changes and marketing documents

• You will ensure market access by incorporating regulatory requirements into the processes

• You will actively support in the complete lifecycle process of our medical devices - starting with product definition till End of Support (e.g. participation in PSGs, CCBs, document reviews)

• You will be providing inputs to the approval of project phases as well as product release

• You are responsible for performing Main Reviews (R-Reviews) during project milestones

• You will support in maintaining and improving of product and process quality (including project related Quality Reporting)

• You will be supporting/consulting software development teams in implementing and realizing the processes defined in QMS/QMP

• You will act as independent reviewer for design reviews acc to QSR 820.30 (e) including complete veto rights and reporting to independent QMR only, with the responsibility of defining and documenting the overall result of the design review

• You will participate in the audits and inspections by external bodies

• You will be monitoring and controlling corrective actions in the development project – in cooperation with safety officer in case of complaints

• You will stay up-to-date with standards and regulations related to  Software as a Medical Device as well as non - Medical Devices

• You will be working with globally distributed teams located in the U.S., Canada, Germany and India

 

Your qualifications and experience:

• You have successfully completed a course of studies in a technical or clinical field, preferably in engineering, medicine, medical engineering or (medical) informatics

• You have experience in process or quality management is a plus as well as knowledge of standards for data exchange between software systems in healthcare (HL7 and FHIR)

• You have many years of professional experience in Quality Management of  Medical Devices, ideally in the software area

• You have a sound knowledge of international laws, standards and regulations for licensing medical devices, and of the business processes of medical device manufacturers (e.g. MDD & MDR, 21CFR 820; ISO 9001; ISO 13485; IEC 62304; IEC 62366; ISO 14971)

• You have knowledge of regulatory requirements for the clinical evaluation of software for medical devices would be a plus

 

Your attributes and skills:

• With your excellent communication, network and moderation skills, you can communicate securely with the internal interfaces and externally with government officials

• With your knowledge of English, you can understand technical documentation (product specifications, risk analyzes, etc.) and use it to derive content for approval documents

• Your personal qualities include a professional approach, teamwork, planning and organizational skills as well as intercultural experience

 

Our global team:

Siemens Healthineers is a leading global medical technology company. 50,000 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:

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.


Organization: Siemens Healthineers

Company: Siemens Healthineers India LLP

Experience Level: Experienced Professional

Job Type: Full-time

Can't find what you are looking for?

Let's stay connected

Can't find what you are looking for?