Senior Regulatory Affairs Specialist
Job no: 610360
Work type: Permanent
Categories: Quality & Regulatory, Asia Pacific, Individual Contributor
As part of this role some duties will include:
- Familiar with Medical Device new regulations from Oct. 2014. Understand registration requirements for new application, can draft overview data and research data independently. Understand clinical trial regulation well and can provide clear requirements for CER. Can work with oversea manufacture to handle new applications independently. Responsible for getting new product approval as quickly as possible. Ensure to get new certificate for extension before license expiration date.
- Have successful experience in secure new registration approval under new regulations for powered-MD and non-powered MD which handled independently.
- To develop and maintain relationships with the key RA stakeholders including NMPA, CMDE and industry groups.
- Have good communication skill with Inspection centre and NMPA.
- Support the follow-up and closure of Corrective and Preventive Actions in consultation with the Recipient Services and Operations Team
- Implement local RA strategies
- Preparation of regulatory submissions, maintenance of registered products and providing input to regulatory strategies, and compliance to major international regulatory standards
- Keep good communication between external authorities and overseas counterparts, accurately convey information.
- Maintain the current certificates and registration documents, follow up latest regulations
- Familiar with medical device type test and drafting technical specification. Work independently to handle Medical Device type testing and registration well through Inspection centre and NMPA.
- Review and maintain Chinese labels and IFU as well as liaisons with manufacturers and distribution centres.
- Assure all marketing, sales and other materials and practices are in conformance with regulatory requirements.
Team Role (Individual contributor):
- Follow relevant quality procedures in order to deliver quality products and services and identify and support the implementation of continuous improvement. Undertake additional quality responsibilities (e.g. audit) when appropriately trained to undertake these responsibilities.
- Contribute ideas on systems and process methods to improve deliverables.
- Work safely, complying with all safety procedures, rules and instructions; and reporting workplace hazards, incidents or injuries to manager.
- Tertiary qualifications in relevant discipline: electroacoustics, electronic engineering, mechanical engineering
- At least 3 years of registration experience in handling both Powered MD and non-powered MD.
- Excellent communication skill
- Diligent, fast learning
- Excellent project management skills
- Excellent verbal and written communication in Mandarin and English languages
- Ability to collaborate and influence across the local (China) and regional (Sydney) offices
- Familiar with the Office applications/software, such as word, excel and powerpoint computer knowledge.
- Experience in multinational companies
- Budget and forecasting experience
Advertised: China Standard Time
Applications close: China Standard Time
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