长沙招聘

说明

Key Areas of Responsibility (KARs): (Indicate what the key areas of responsibility in the job are using the same KARs as used in PPM where applicable. Strive for KARs that are concise and that can be easily understood.)

· Regulatory Affairs representative for the Digital X- Ray Programs who will assist with regulatory issues related to such items as labeling and marketing ideas, prepares documents required in the Development Life Cycle, and recommends strategies for most efficient and effective approvals of regulatory applications for a program. Defect and complaint reviews for program teams, provides guidance to the team on risk assessment and required corrective actions to meet regulatory requirements.
· Responsible for the coordination and preparation of document packages [China SFDA, 510(k) Pre-market Notifications] for regulatory submissions.
· Drives improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System. Reviews and recommends changes for design process and manufacturing procedures to maintain quality and regulatory compliance
· Key role in external audits such as FDA, 3rd party external regulatory agencies like SFDA, KFDA, JPAL, etc. and notified body audits. Implements internal or external quality system audits.
· Provide leadership and guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X & ISO 13485, Canadian CMDCAS, etc.

Specifically, the individual will be responsible for all Regulatory deliverables for all Digital X-Ray programs and projects that are led out of Philips Suzhou. This will be achieved by:
· Developing robust Regulatory project plans, and working closely with Quality colleagues to develop a comprehensive Q&R project plan.
· Active participation in all relevant program/project meetings to provide guidance on world wide regulatory requirements for medical devices, as applicable.
· Product registrations/approvals with the relevant regulatory authorities.
· Coordination and preparation of robust registration dossiers for regulatory submissions. This is achieved by working seamlessly with experts from all relevant functional areas in Digital X-Ray.These individuals may be located anywhere in the world.
· Participate in and advises and prepares the Suzhou team(s) for external government product audits by China, Korea, Japan, USA and other inspection agencies as needed.
· Compile all materials required for submissions, license renewals, initial product reports and annual product reports, in addition to reviewing and recommending changes for labeling, and clinical protocols so as to maintain regulatory compliance.
· Keeping abreast of current regulatory procedures and changes in all relevant geographies.
· Participating in direct interaction with regulatory agencies on defined matters.
· Recommending strategies for earliest possible approvals of clinical trials applications.
Job Knowledge, Skills and Experience: (Specify the educational background, qualifications and experience typically required to perform the job fully and effectively. If applicable, also indicate any desired skills for the job.)

· Bachelors of Science degree in biomedical engineering, or in related technical or business discipline.
· Minimum of 5 years of experience in a medically regulated and technical environment with experience in a medical device company (FDA Class I or II equivalent – Class III a plus).
· Must have experience with successful preparation and submission of SFDA, 510(k), PMA, or international documents or registration and marketing of medical device worldwide.
· Experienced in design control process
· working knowledge of medical device regulations (21CFR) and FDA laws
· Passion for research
· Experience in supporting international registrations desirable.

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