南京招聘

职位描述：
I. Summary of Position
The Regulatory Affairs Specialist will ensure medical device regulatory requirements are met for marketing of Hu-Friedy products. This role manages medical device regulatory submissions, registrations, and internal policy and procedures needed for compliance to international standards and regulations. Internally, this position interacts with all functions (e.g. engineering, quality, sales, marketing, procurement and manufacturing) and will work with all levels (e.g. management and support staff). Externally, this position interacts with regulatory agencies, distributors, consultants, customers, partners, and vendors.

II. Principal Accountabilities
1. Manage regulatory files and databases to ensure prompt and accurate access to regulatory information and provide reports to Management concerning current, pending, and future registration activities.
2. Prepare and assemble documentation for product or facility registrations in local or international markets, as requested.
3. Keep track of the filing/registration process and resolve any issue timely to ensure earliest possible filing/registration.
4. Build up or work with headquarters Regulatory team to sustain a reliable and professional relationship with regulatory authorities (e.g., FDA, SFDA).
5. Interpret Regulatory Agency requests and correctly apply them as appropriate for assigned devices.
6. Communicate regulatory progress/status to operations team, provide instruction and advice to ensure effective and smooth operation of company.
7. Continuously monitor the development of regulations and policies of medical device, and ensure the potential impact to company business have been thoroughly evaluated and well communicated.
8. Provide coaching and trainings to management and employees on regulatory requirements of related medical instruments.
9. Research new and/or modified standards, regulations / laws and determine applicability to the organization and/or product.
10. Ensure the content, context, organization and overall quality of all regulatory documentation is adequate and sufficient to meet all regulatory requirements, commitments and agreements.
11. Ensure documents are certified and legalized or notarized, as required.
12. Coordinate internally external audits from customers and notified bodies. Monitor/track open non-conformances/observations from internal and external audits as assigned.
13. Review change requests for packaging, literature, work instructions/procedures, production BOM/routers and other controlled document for regulatory compliance.
14. Maintain controlled documents for Quality Management System.
15. Participate in professional associations, industry/ trade groups (local/regional/international) and appropriate standards organizations
16. Support other department requirement and other duties the manager may assign.

III. Functional Knowledge, Skills & Abilities
This position requires an individual with:

1. University graduate with Bachelor degree or above.
2. Excellent communication skills, active team player.
3. Above 3 years hands-on experience in Regulatory Affairs of Medical Device.
4. Profound ISO9000 or ISO13485 knowledge and auditing experience.
5. Work well with minimal supervision, balancing a variant of tasks and priorities.
6. Computer literate and comfortable using MS Word, Excel, and Powerpoint Softwares.
7. Fluent in written and spoken English. 举报 分享

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体验，以满足中国牙科诊疗水平日益发展提高的要求，最终与中国社会实现共同进步。

为满足Hu-Friedy在中国的业务增长, 我们诚邀优秀的您与我们一起成就未来！