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信息概要
| 【信息类别】雇主招聘 | 【职业分类】专业技术 |
| | 【职位概况】全职 - 长期工 - 白班 | | 【大致薪水】[ 面议 ] | 【上班日期】2019年9月1日 | | | 【雇主描述】[ 未填写 ] | 【所在地区】滑铁卢
查看地图，确定具体方位
| 【招聘人数】1 人 | | 【工作地点】85 Northland Rd | | | 【语言要求】英语流利 / 国语流利 |
| 联络信息
| 【联 系 人】lenano |
| | 【联系电话】[ 未提供 ] | 【电子邮件】[ 发送邮件 ] | | 【其他电话】[ 未提供 ] | 【传真电话】[ 未提供 ] |
| 详细介绍
Job Responsibilities
The Regulatory Affair and Quality Assurance Specialist position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the Canadian regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Leads and supports necessary regulatory activities required for product market entry.
Primary Responsibilities include but are not limited to:
• Supports all quality activities to ensure product sustainment and new product development meet regulatory requirements and customer quality expectations
• Administer and manage all aspects of an effective Quality Management System
• Ensures that the requirements of 21 CFR part 820 and Part 803 and ISO 13485 standards and any other applicable government or international standards are implemented and maintained
• Lead and support all internal and external audit activities (FDA, ISO, Supplier Quality, etc.)
• Work with executive staff, R&D team and Production team to achieve LeNano mission, vision and objectives
• Communicate and drive the overall RA/QA vision, quality goals and achievements to all employees as well as executive staff on a regular basis.
• Creates, reviews and approves engineering changes. Develops and implements quality procedures, work instructions and forms to coincide with operational and process related changes to daily work flow
• Prepares robust regulatory applications to achieve departmental and organizational objectives.
• Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
• Supports the product release process or reviewing and approving requests for product release.
• Drafts and reviews protocols and reports to support regulatory submissions.
• Oversee all inspection activity including incoming components and finished goods
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Potentially participates in R&D and production activities.
• Performs other related duties and responsibilities, on occasion, as assigned.
Job Qualification Required
• Minimium BA or BSc degree (science or engineering preferred)
• Previous experience in healthcare/medical device area, either Product development or RA/QA, will be a plus
• Regulatory and Quality experience preferred
• Laboratory/Industry hands-on work experience preferred
• Responsible and willingness to take responsibility
• Ability to work within a team and as an individual contributor in a fast paced changing environment
• Ability to leverage and/or engage others to accomplish projects
• Strong verbal and written communications with ability to effectively communicate at multiples levels in the organization. Multi-language (English& Chinese) preferred
• Strong organization and follow-up skills, as well as attention to detail
please contact [email protected].
| 其他信息
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发表于 2019-8-6 09:06:13