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11519en
- Permanent
- English, German
- Not Applicable*
- Legal, Regulatory & Compliance
- Zurich
- Healthcare & Life Sciences
Skills
Medical Devices, Regulatory Compliance, Quality, ISO, Medical Device,
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This vacancy has now expired
On behalf of our client, a leading and reputable medical device company, Swisslinx is seeking a highly motivated Regulatory Compliance Manager to join their team in Zurich.
The main purpose of this role would be to lead a small team of quality specialists, act as subject matter expert on all relevant standards and regulations, as well as be responsible for overall quality.
Our Mission:
- Maintain compliance of internal and external standards, through the enforcement of quality assurance activities and monitoring
- Liaise with R&D and users on complaints / flaws and suggest mitigations and solutions
- Oversee and delegate tasks to a small group of quality specialists
- Provide relevant training to colleagues to ensure product quality, sound performance and general safety
- Keep updated on domestic and internal quality standards and regulations
- Assist external bodies and internal departments with inspections and be the first point of contact for agents during said inspections
- Spot flaws in systems and implement improvements as appropriate
- Educate on compliance issues to personnel
Your background:
- Degree in Engineering, Science, or related
- At least 3 years of experience in the medical device sphere
- Strong understanding of ISO, EU and US standards related to medical device manufacturing and sales
- Experience supervising and leading a small team
- English and German fluency is a must
Candidates must have a valid Swiss or European permit or work rights to be considered for this position. If you would like to be considered for the role, please apply directly or send your CV to alexi.donadoni@swisslinx.com.
We look forward to receiving your application!
The main purpose of this role would be to lead a small team of quality specialists, act as subject matter expert on all relevant standards and regulations, as well as be responsible for overall quality.
Our Mission:
- Maintain compliance of internal and external standards, through the enforcement of quality assurance activities and monitoring
- Liaise with R&D and users on complaints / flaws and suggest mitigations and solutions
- Oversee and delegate tasks to a small group of quality specialists
- Provide relevant training to colleagues to ensure product quality, sound performance and general safety
- Keep updated on domestic and internal quality standards and regulations
- Assist external bodies and internal departments with inspections and be the first point of contact for agents during said inspections
- Spot flaws in systems and implement improvements as appropriate
- Educate on compliance issues to personnel
Your background:
- Degree in Engineering, Science, or related
- At least 3 years of experience in the medical device sphere
- Strong understanding of ISO, EU and US standards related to medical device manufacturing and sales
- Experience supervising and leading a small team
- English and German fluency is a must
Candidates must have a valid Swiss or European permit or work rights to be considered for this position. If you would like to be considered for the role, please apply directly or send your CV to alexi.donadoni@swisslinx.com.
We look forward to receiving your application!
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