WE SPECIALISE IN FINDING FANTASTIC OPPORTUNITIES
FOR DIGITAL AND DATA SPECIALISTS WITH THE MOST INNOVATIVE BUSINESS ACROSS EUROPE AND THE USA.
Quality Assurance Manager (Medical Devices)
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Location
Basel, Switzerland
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Sector:
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Job type:
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Salary:
Negotiable
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Contact:
Thomas ONeill
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Email:
thomas.oneill@darwinrecruitment.com
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Job ref:
JN -072020-86613_1593765502
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Published:
7 months ago
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Duration:
12 Months
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Expiry date:
2020-08-02
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Startdate:
ASAP
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Consultant:
#
We are currently searching for a Medical Devices Quality Assurance Manager to be located in Basel on a 12 month contract.
Responsibilities
- Develop, implement, communicate, and maintain global regulatory strategies and plans for high-tech medical devices
- Creating, reviewing, and maintaining regulatory related technical documentation
- Identify and communicate relevant guidance, standards, and regulations
- Part of the team reviewing product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining if regulatory submissions are required
- Working alongside cross-functional teams to obtain relevant information and subsequent review of submission content as needed, assisting with reviews of international product technical documents, marketing, and labelling materials
- Supporting the maintenance of regulatory files and tracking databases
Requirements
- Minimum 3 years of experience in European Medical Device industry and regulatory
- Master's degree in Regulatory Affairs, Engineering or Life Sciences
- Strong knowledge of ISO 13485, ISO 9001, QSR, Council Directive 93/42/EEC and Regulation 2017/745
