Purpose of the Job:

The Professional Regulatory Affairs participates in all required registration activities for Advanced Bionics medical devices in China and Hainan.

Key Responsibilities:

·      Prepare submissions, interact effectively with regulatory agencies and negotiate submission issues as needed

·      Provides regulatory intelligence (China/Hainan) to RA Development teams to determine in-country requirements (testing, labeling, etc.)

·      Build and maintain relationships with the CMDE, local testing labs, and other health authorities.

·      Provide support to local In-country RA affiliates who interact with regulatory authorities to assure timely approvals and continued product access

·      Proactively and timely tracking evolving keeping company informed of regulatory requirements and external standards in International markets

·      Supports product launch/release activities

·      Supports post market regulatory compliance activities for international product approvals

·      Support product recall management and process local implementation

·      Other duties as assigned or required

Additional Key Responsibilities ：

·      Review and assess the RA inputs document in order to discuss the project and its scope and determine country-specific requirements such as testing requirements, labeling requirements as part of the Regulatory Inputs Documents.

·      Produce subsequent submissions (License Renewals, Annual Reports, additional information requests, etc.) to facilitate the maintenance of these approvals.

·      In conjunction with Clinical Research, help in the preparation of CERs according to NMPA Clinical requirements.

·      Ensure compliance with pre-market and post-market approval requirements.

About Us：

This position will support the following client through Manpower Group’s service outsourcing program.

Advanced Bionics, known as AB Cochlear, develops state-of-the-art cochlear implant technologies and ships its products worldwide so that people with hearing loss can return to the world of sound and enjoy fuller, happier lives sooner. AB’s service philosophy is simple: “Users and quality come first,” and the company continually strives to deliver better hearing solutions and attentive, end-to-end support.

As a member of the Sonova Group, Advanced Bionics has worked closely with Phonak since 2009, merging the DNA of both brands so that their shared technology platform can intelligently synchronize acoustic and electrical stimulation signals. The result: users enjoy richer sound quality through true binaural hearing. Headquartered in Switzerland, the Sonova Group is the world’s leading innovator in hearing-health solutions, offering consumers everything from personal audio devices and wireless communication systems to hearing-care services, hearing aids, and cochlear implants.

Qualifications：

·      Bachelor’s Degree (and/or 3-5 years of equivalent work experience)

·      Bachelor's degree in a technical or scientific field (e.g., Biochemistry, Biomedical, Electrical, or Chemical Engineering), or equivalent practical experience is preferred

·      3-5 years of experience in pre/post market medical device regulatory affairs

·      Experience in China/Hainan regulatory requirements and maintaining certifications for the life of a medical device

·      Experience providing regulatory strategy and guidance for China/Hainan.

·      Expertise in Class III medical device registration with the Chinese NMPA.

·      Experience interacting with regulators during the market approval process is preferred.

·      Experience providing regulatory support for products under development (e.g., classification assessments, review engineering documents, risk analyses, test protocols and reports) is preferred.

Other Competencies：

·      Good working knowledge of NMPA regulatory requirements (technical documentation, labeling, etc.).

·      Excellent writing, proof reading and data management skills

·      Excellent time management and problem solving skills

·      Ability to change priorities and direction when necessary

·      Work effectively in a team setting, collaborative

·      Value transparency, honesty and work ethics and apply them in relationships and own work

·      Admit faults and seek guidance as necessary

·      Be open-​minded, objective, and accountable for own actions

·      Be reliable and trustworthy

·      Project and time management

·      Effective communication

·      Ability to work independently

·      Ability to manage time effectively and independently

·      Ability to prioritize among multiple projects, tasks, and duties

·      Ability to manage pressures, distractions and stress

·      English (Spoken, Written) required

·      Proficiency in Microsoft Office suite.

·      Experience with Agile PLM, SAP and Regulatory Information Management Systems is preferred.