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 global team as Regulatory Affairs Manager to support
Ultrasound business in China.
Your tasks and responsibilities: You should ensure products and quality
management system complying with relevant international / national standards
and regulations through the entire product life cycle.1. You will be
responsible for medical device registration / homologation in NMPA and other
national competence authority. Renew and maintain all licenses and certificates
according to business development requirements.2. You will establish, maintain
and optimize product registration / homologation and other compulsory
certification process, ensure all documentation for product licensing are
properly archived and maintained.3. You will establish, maintain and improve
quality management system. Ensure the quality management system is compliance
with ISO 13485, China GMP and other regulatory requirements.4. You will be
responsible for Sub-contractor quality and process management. Regular audit to
sub-contractor, include incoming, process and outgoing quality control.5. You
will be responsible for Post market surveillance management. Handling of
adverse events, post market surveillance plan and report. Medical device
reporting to authority.6. You will communicate with local authority / NMPA and
SHS China RA team for regulatory affairs, and improve the efficiency of product
registration.7. You will coordinate with relevant colleagues for authority
quality system audit, factory inspection.
Your qualifications and experience: 1. You have Bachelor’s degree or above,
major in Biomedical Engineering, Electrical Engineering, Physics, Mechatronics,
Computer Science, etc.2. You over 5 years’ regulatory affairs and quality
management system working experiences.3. Hands-on MAH experience is plus.