Lead Quality / Regulatory Affairs Manager Jobs Opening in Siemens Technology and Services Private Limited at Bangalore
Job Description
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
Job Particulars
Role management trainee
Education Diploma, B.Com, M.Com, BBA/BBM, BCA, BE/B.Tech, MBA/PGDM, BSc, MCA, ME/M.Tech, MS, MSc, PG Diploma
Who can apply Freshers and Experienced (0 to 3 Years )
Hiring Process Face to Face Interview
Employment TypeFull Time
Job Id1484798
Job Category Diploma , BSc/BCA/BBM , Management
Locality Address
State Karnataka
Country India
About Company
Siemens India is a technology powerhouse that has stood for engineering excellence, innovation, quality and reliability. The company focuses on the areas of electrification, automation and digitalization. It is one of the leading producers of energy-efficient, resource-saving technologies; combined cycle turbines for power generation; and power transmission solutions. Siemens is a pioneer in infrastructure solutions and automation and software solutions for industry. The company is also a leading supplier of medical imaging equipment – such as computed tomography and magnetic resonance imaging systems – and a leader in laboratory diagnostics as well as clinical IT. At the end of September 2016, Siemens India had around 16,000 employees (Number of employees is 16,000 including all group companies of Siemens in India). Siemens Limited, in which Siemens AG holds 75% of the capital, is the flagship listed company of Siemens AG in India.
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