What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at NATUS?
Senior Regulatory Affairs Specialist
Location: Suzhou
Welcome to Natus Medical Incorporated:
We’re the leading manufacturer of medical devices and software for a range of specialties, including new-born care, neurology, sleep, hearing and balance markets. Our mission is to improve patient outcomes in target markets through innovative screening, diagnostic and treatment solutions.
The success of our company depends on our employees. This is where you come in.
Summary:
The Senior Regulatory Affairs Specialist prepares and submits documentation to Local Labs/NMPA/Local FDA directly to ensure product registration timely and properly.
Main Responsibilities:
Other duties may be assigned.
§ Effective projects management (not limit to local medical devices, imported medical devices, local medical device production cert) to achieve and demonstrate best practices in line with the goals of the regulatory department.
§ Interfaces with manufacturing, engineering, R&D and quality representatives to provide consultation on the impact of proposed changes to product, processes and the quality system.
§ Keep good communication with cross-functional departments to support registration projects and China business.
§ Prepare and maintain NMPA submissions for the Natus portfolio of products.
§ Develop and maintain internal procedures to ensure compliance to regulatory requirements.
§ Participate in Regulatory body audits, such as FDA, Notified Bodies, Competent Authorities, MDSAP, NMPA and other global regulatory agencies.
§ Support RA Manager to deal with requests from DP and China sales, PMS issues as reuqired.
§ Demonstrate and actively promote highest level of professional regulatory discipline.
§ Liaises with both middle and senior management on any regulatory issues relating to their area.
§ Support QA on Adverse Event, vigilance and the complaint as required.
§ Development and collation of data for submission to the notified bodies if required.
§ Ensure continued compliance to regulatory requirements by interpretation of new medical device regulations, standards, and country specific guidance documents.
§ Being the bridge for Natus to follow up NMPA Regulation updates in time.
§ Support facility to manage Label and IFU in time.
§ Support registration dossiers templates creation with the NMPA regulations update.
Qualifications and Requirements for the Role:
Bachelor's degree from four-year college or university, preferred in an engineering or scientific discipline (Electronics, Mechanical or Chemistry Sciences, Physics or related) with minimum 4 years related experience and/or training; or equivalent combination of education and experience.
Possess a good working knowledge of regulatory expectations and industry practices including industry standards GB/YY/IEC, ISO13485.
Work experiences in the global medical device company at RA roles for continuous 3 years.
Good communication and coordination ability, and problem solving ability;
Able to work independently, proactive working attitude;
Strong sense of responsibility, team work spirit
Excellent organizational and influencing skills.
Strong written and verbal communication skills in English and Chinese required
Natus Medical Incorporated is an Equal Opportunities Employer
#LI-SH1
