位于北京市崇文区的 2 个优质technician职位（正在招聘！）

Specialist, Regulatory Affairs, BD Advanced Patient Monitoring
Edwards Lifesciences —北京市
- 全职
2天
Quality Control Technician
ABB Beijing Drive Systems Co. Ltd. —北京市
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Specialist, Regulatory Affairs, BD Advanced Patient Monitoring
Edwards Lifesciences —北京市
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing…
2天
Quality Control Technician
ABB Beijing Drive Systems Co. Ltd. —北京市
Well document product quality record and support delivery quality improvement. Improve testing process/tools/equipment and instruments to improve efficiency and…
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Specialist, Regulatory Affairs, BD Advanced Patient Monitoring

Edwards Lifesciences -
北京市

立即申请

职位详情

全职
2 天前

完整职位描述

Job Description

Becton Dickinson (BD) recently completed the acquisition of the Edwards Critical Care business. This position is part of the Critical Care division, and as such will become a part of the BD organization in the future. Critical Care will operate as a separate business unit, called Advanced Patient Monitoring (APM) within BD's medical segment, aligning with BD's smart connected care approach. BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. If you are invited to interview for this position, a recruiter will provide further details about this exciting transition. Learn more about BD at bd.com

Completes and maintains regulatory approvals and clearances of assigned products.

You will make an impact by...

Prepare and complete product registration tasks covering the new product registration, the registration amendment, and the renewal registration. Ensure product tests/samples meet safety and performance requirements of regulatory agencies in collaboration with lab technicians
Prepare clinical trial and evaluation report applications according to government regulations, hospital ethics committee needs, and company requirements for submission.
Create local language labels and Instruction For Use in compliance of country regulations before passing them to Supply Chain
Liaise with regulatory agencies to facilitate and expedite review and approval of company products, registrations, submissions, reformulations etc.
Maintain proper records in the Module Change Request and JDE system to comply with local and company regulatory and quality requirements.
Serve as regulatory liaison throughout product lifecycle. Participates in regulatory strategy and operating plans.
Handle product recall reporting to regulatory agencies, for products exhibiting non-compliance
Review marketing advertisements to ensure compliance to regulations and submit to FDA for approval
Other incidental duties: Serve as regulatory representative to sales & marketing team, clinical team and regulatory agencies.

What you'll need (Required):
Bachelor's Degree in related field, 3 Years experience previous related experience Required or
Bachelor's Degree in scientific discipline (e.g., Biology, Microbiology, Chemistry) Experience in preparing domestic and international product submissions Preferred
Other: Coursework, seminars, and/or other formal government and/or trade association training Required

What else we look for (Preferred):

Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving, organizational, analytical and critical thinking skills
Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
Solid knowledge and understanding of global regulatory requirements for new products or product changes.
Solid knowledge of new product development systems
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Work is performed independently on complex projects and/or lines of work and reviewed for accuracy and soundness
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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Specialist, Regulatory Affairs, BD Advanced Patient Monitoring

Quality Control Technician

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