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RA Consultant Medical Devices £60ph Surrey - Immediate Start
Eingestellt von Real Staffing Group aus Frankfurt am Main
Gesuchte Skills: Consultant
Projektbeschreibung
Responsibilities;
- Regulatory and Quality Assurance functions of the healthcare businesses, providing leadership and strategic advice.
- Compliance with the regulatory frameworks covering the development, approval and distribution of the healthcare products. This includes clinical trials and investigations, interactions with healthcare professionals, transportation/shipping, hazardous materials, ISO 9001, ISO 13485, medical device regulations and directives for both general medical devices and in vitro diagnostics, FDA CFR, cGMP and other pertinent regulations and standards that apply, including development and maintenance of policies, SOPs and procedures.
Requirements;
7 years direct experience in regulatory affairs in a regulated medical device industry
Extensive knowledge of the medical device regulatory framework in Europe and theUS, including:
- Directives 93/42/EC
- FDA CFR; and
- the CE marking, 510(k) and FDA PMA processes
- Extensive knowledge of domestic and international quality standards, including ISO 13485, FDA CFR Part820, cGMP, Japanese Ordinance 169
- In vitro diagnostic (IVD) industry experience preferred with knowledge of 98/79/EC (in vitro diagnostics
Please contact Steven Ruddy from Real Pharma on 0207 758 7322
RA Consultant Medical Devices £60ph Surrey - Immediate StartTo find out more about Real please visit www.realstaffing.com
Projektdetails
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Einsatzort:
Surrey, Vereinigtes Königreich
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Organisation/Management