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Quality & Regulatory Affairs Officer

Job Description

Job Highlights
  • Maintain/update Quality processes
  • Audit internally on the Quality system
  • Flexible Working, Birthday Leave, 5 days work week

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 Quality & Regulatory Affairs Officer.
 Your mission and responsibilities:
  • Good knowledge in ISO 9001.  Maintain/update Quality processes, with formal roll-out of SOPs and training on stakeholders. This includes working with various functions in the organization to roll-out the processes.
  • Audit internally on the Quality system in Hong Kong and audit crucial suppliers to ensure that regulatory and quality requirements are met.
  • Assist in driving process improvement within the company as the Quality person and ensure regulatory and quality compliance.
  • Timely manage & coordinate medical device & IVD listing submissions to MDD. Provide updates on registration activities, and approval status of medical devices to Mangers.
  • Ensure regulatory compliance including post-marketing activities and reporting.
  • Familiar with Hong Kong regulations & license requirements concerning medical devices and the Hong Kong Medical Device Administrative Control System (MDACS).

Your qualifications and experiences:
  • Degree in Science
  • Minimum 3 years experience in quality and regulatory, knowledge in cold chain management would be an advantage
  • Experience with ISO14001 and ISO45001 would be an advantage although not necessary
  • Certified ISO9001, ISO13485 internal auditor with sound QMS  audit experience
  • Candidate with more experience will be considered as Senior Quality & Regulatory Affairs Officer

How to Apply:
We are an equal opportunity employer and welcome applications from all qualified candidates. Attractive remuneration package and excellent career prospects will be offered to the right candidate. Interested persons, please send your full resume with expected salary in your application by clicking "Apply Now" , email to hchr.hk@siemens-healthineers.com or by mail to: 
The Human Resources Manager Siemens Healthcare Ltd. Units 901-902 & 908B, 9/F, Tower B, Manulife Financial Centre, 223-231 Wai Yip Street, Kwun Tong, Hong Kong
Applicants not hearing from us within 4 weeks from the date of advertisement may consider their applications filed for future reference. We reserve the right to review applications received for suitability for other posts within the company. Personal data provided by job applicants will be used strictly for recruitment related purpose only. We shall retain the personal data of unsuccessful applicants for a period of 1 year. 
Our global team:  We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. As an equal opportunity employer, we welcome applications from individuals with disabilities. We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open.
To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes. 


Organization: Siemens Healthineers

Company: Siemens Healthcare Limited

Experience Level: Experienced Professional

Job Type: Full-time

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