...looking for an experienced skilled personality as a
Regulatory Affairs Manager | 100%
Ref. No. 6448
Location:
Solothurn
|... ...medical device
Expertise in Active Medical Devices related regulations and guidance documents in EU and US
Excellent...
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Teilzeitarbeit
Schichtarbeit
...Sciences or equivalent experience
~At least 4 years of professional experience in Regulatory Affairs with focus medical device
~Expertise in Active Medical Devices related regulations and guidance documents in EU and US
~Excellent organizational and people skills
~Very...
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...Zusammenarbeit mit sämtlichen involvierten Teams, insbesondere Produktentwicklung und unterstützenden Funktionen wie beispielsweise Regulatory Affairs
Ihr Profil
Abgeschlossene Grundausbildung im Bereich Technik oder Naturwissenschaften
Teilnahme an einer ISO 14971...
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...Minimum Education Requirements:
Bachelor's degree in biotech, pharmaceuticals, or related field.
Solid understanding of cGMP regulations and biotech manufacturing processes.
Minimum Experience Requirements:
Minimum 7 years of experience in pharmaceutical...
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...Zusammenarbeit mit sämtlichen involvierten Teams, insbesondere Produktentwicklung und unterstützenden Funktionen wie beispielsweise Regulatory Affairs
Ihr Profil
~Abgeschlossene Grundausbildung im Bereich Technik oder Naturwissenschaften
~Teilnahme an einer ISO 14971...
Empfohlen
...High school diploma or equivalent; Bachelor’s degree preferred.
Strong understanding of manufacturing processes and cGMP regulations.
Minimum Experience Requirements:
Minimum 6 years of experience in a GMP environment, preferably in biotech or pharmaceutical...
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...engineering (IREB certification is an advantage)
~Experience in product development of mechatronic medical devices
~Experience in medical technology or other regulated industries
~Very good communication skills
~Very good English skills, good German skills...
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...addressing customer inquiries, resolving issues and ensuring a smooth installation process.
You stay updated on industry trends, regulations, and competitive offerings to maintain a competitive edge in the market.
You manage different report on sales activities....
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...involvement in drug substance and drug product manufacturing, including reviewing validation documents, ensuring compliance with GMP regulations, and overseeing Quality Assurance activities related to facility and equipment qualification.
Qualifications
~ Bachelor-s...
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Vollzeit
...open communication channels with site stakeholders, providing regular updates to leadership, and serving as a subject matter expert... ...practical knowledge and application of cGMP compliance and related regulations
~ Fluent in English (written and oral)
~ Practical...
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Temporär
Schichtarbeit
...systems in a large-scale data center environment.
Perform regular system maintenance and upgrades to ensure optimal performance... ...Maintain a high level of security and compliance with relevant regulations and standards
If you meet the qualifications and are interested...
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Teilzeitarbeit
Freelance
Remote job