兰里 Langley 医疗器械工厂QA&RA
Position Summary
The Regulatory Affairs/ Quality Assurance (RAQA) Specialist works with a cross functional project team to bring medical products to the market and to ensure ongoing compliance while continuing to develop their quality assurance and regulatory skills.
Major Responsibilities
Review of documentation generated during product development against current Design Control Process and regulatory requirements
Create and maintain the Risk Management Documentation for new and existing products
Support product and project managers as well as wider organization to meet product regulatory requirements for product registrations to support product launches.
Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy
Write or update standard operating procedures to ensure that they reflect current regulatory requirements.
Identify relevant guidance documents, or consensus standards and provide interpretive assistance.
Support creation of technical files for new products and implement updates for changes to existing products
Working effectively in a team environment to ensure not only individual tasks are accomplished, but that team and department objectives are achieved.
Qualifications
Required Education, Experience, Skills
Education:
Bachelor's degree in Engineering or Life Sciences;
Experience/Skills:
Minimum of two year experience in RA/QA within medical device or pharmaceutical industry;
Experience with ISO 13485, FDA GMP and Canadian Medical Devices Regulations;
Experience with support of cross functional new product development from RAQA perspective including risk management, review of technical files, new product approval and registration
Ability to effectively communicate to all levels within the organization and influence change outside of the local span of control
The ability to adapt in an environment of change, uncertainty, and ambiguity; Can pragmatically make decisions in a timely fashion, especially when there is not a clear path
Contact： Jack Phone: 604-331-0016 Cell Phone: 778-938-0682
jack@essenlife.com
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The Regulatory Affairs/ Quality Assurance (RAQA) Specialist works with a cross functional project team to bring medical products to the market and to ensure ongoing compliance while continuing to develop their quality assurance and regulatory skills.
Major Responsibilities
Review of documentation generated during product development against current Design Control Process and regulatory requirements
Create and maintain the Risk Management Documentation for new and existing products
Support product and project managers as well as wider organization to meet product regulatory requirements for product registrations to support product launches.
Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy
Write or update standard operating procedures to ensure that they reflect current regulatory requirements.
Identify relevant guidance documents, or consensus standards and provide interpretive assistance.
Support creation of technical files for new products and implement updates for changes to existing products
Working effectively in a team environment to ensure not only individual tasks are accomplished, but that team and department objectives are achieved.
Qualifications
Required Education, Experience, Skills
Education:
Bachelor's degree in Engineering or Life Sciences;
Experience/Skills:
Minimum of two year experience in RA/QA within medical device or pharmaceutical industry;
Experience with ISO 13485, FDA GMP and Canadian Medical Devices Regulations;
Experience with support of cross functional new product development from RAQA perspective including risk management, review of technical files, new product approval and registration
Ability to effectively communicate to all levels within the organization and influence change outside of the local span of control
The ability to adapt in an environment of change, uncertainty, and ambiguity; Can pragmatically make decisions in a timely fashion, especially when there is not a clear path
Contact： Jack Phone: 604-331-0016 Cell Phone: 778-938-0682
jack@essenlife.com
提示:
联系信息
| 发布者: | amanda.essenlife |
| 电话: | (778) 938-0682 |
| 邮件地址: |
地址
| 城市: | 兰里 |
| 地址: | #101 19661 96 Ave Langley, BC, Langley, BC |
| 地图: |
