重庆招聘

Duties & Responsibilities: 

• Assist the Global Regulatory Affairs team in the preparation and submission of regulatory applications to obtain CFDA registration approvals to commercially distribute the company’s medical device products;
• Responsible and accountable for conducting all China’s new or renewal registration submission as well OEM with the support from Irvine global regulatory team   
• Support Masimo China operations with business licenses and renewals;
• Regularly Update and maintain Regulatory Submission Summary and Registration Timelines;
• Assist in development, implementation, and maintenance of Good Supplier Procedures (GSP) for Masimo China office per CFDA regulations;
• Assist in managing the maintenance of regulatory affairs files (e.g., submission files, registration standard and certificates, business licenses) and distribute information as required to support key stakeholders;
• Work with Irvine engineers or quality assurance or 3rd party test laboratories on CFDA test requirements as specified per CFDA regulations for testing Masimo medical devices for China market;
• Provide guidance on CFDA requirements (i.e. electrical safety, EMC, software);
• Provide input to engineering teams to assure that CFDA regulatory requirements and standards are incorporated in the product development process and design/manufacture of the products;
• Participate in the engineering change order process, by reviewing engineering and manufacturing document release and changes, as requested;
• Assist in representing the Company before the China governing authority or CFDA;
• Provide counsel, training, and interpretation of CFDA regulatory requirements to Global RA team;
• Support QA and QC in developing and executing compliance activities and corrective actions involving regulatory authorities;
• Performs other duties or special projects as assigned;

 

Minimum & Preferred Qualifications and Experience: 

Minimum Qualifications:

• Three to five years of documented work experience in a CFDA regulated medical device company;
• Working knowledge of CFDA medical device regulations;
• Computer Proficiency with MS Office (Word/Excel/Outlook/PowerPoint);
• Excellent verbal and written communication skills;
• Excellent prioritizing, organizational, and interpersonal skills;
• Excellent documentation skills including record maintenance/ tracking and understand document traceability;
• A detail-oriented individual with a “can do” attitude and ability to work in a team environment as well as individually with minimal supervision;
• Ability to work in a fast-paced environment with multiple tasks/projects;

Preferred Qualifications:

• Experience in patient monitor systems, hospital-based products, software or electronic device products;
• Experience with medical device safety certification testing process;
• Experience interacting with regulatory bodies such as CFDA

 

Education:

Bachelor’s degree is required, preferably in life sciences, engineering, or business. Graduate degree is preferred.

Masimo (NASDAQ: MASI) is a global medical technology company that develops and manufactures innovative noninvasive patient monitoring technologies, including medical devices and a wide array of sensors. A key medical technology innovator, Masimo is responsible for the invention of award-winning noninvasive technologies that are revolutionizing patient monitoring, including Masimo SET？ pulse oximetry, Masimo Rainbow Pulse CO-Oximetry and new Masimo noninvasive and continuous total hemoglobin (SpHb?) monitoring technology. The recent introduction of the first-and-only FDA-cleared technology that noninvasively and continuously measures total hemoglobin without a painful needle stick and invasive blood draw is expected to open new markets and significantly expand the company’s growth opportunities.