Senior Regulatory Specialist, China

Overview:

ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.

Job Summary:

This position will report to the Senior Regulatory Affairs Manager. The Primary role of the Specialist within the company is to assist Regulatory Affairs department to implement and administrate of organization activities to support and ensure regulatory compliance.

Essential Functions:

• Understands and has working knowledge of China medical regulations,
• Understands and has working knowledge of APAC, FDA medical device regulations, European Medical Device Directives, and/or other global regulations, ISO 13485 standard is a plus
• Participates in product core teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develops, documents and implements a regulatory strategy plan around product development goals
• Prepare technical dossier for submission to NMPA
• Prepare responses to agency's questions with good writing and communication skills
• Provide impact assessment to change orders for compliance with China regulations and standards
• Implement submission templates
• Monitors and maintains regulatory files in good order
• Monitors and maintains product licenses in good order
• Maintains current knowledge of device regulations, guidance and standards applicable to device product submissions. Analyzes the information and provides updates
• Participates in department improvement activities. Makes recommendations for process improvements to improve efficiency and accuracy of device submissions and other procedures.
• Assist with device recall activities
• Assist with on-site audits conducted by the authorities
• Participate as an auditor in internal audit activities
• Report directly to Senior Regulatory Affairs Manager

Skill Requirements:

• Proficient in Microsoft Office, Adobe Acrobat DC
• Able to work independently and in a team, responsible and positive work attitude
• Organised, results-oriented and able to work under pressure

Required/ Preferred Education and Experience:

• University Degree with 3 to 5 years of Regulatory Affairs experience preferably in healthcare medical devices industry

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job.  Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity.  Essential and marginal job functions are subject to modification.

ZOLL Medical Corporation appreciates and values diversity.  We are an Equal Opportunity Employer M/F/D/V.

ADA:  The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.