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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

A contract opportunity with a leading global medical technology company inHullspecialising in medical devices.

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

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Organisation/Management

  • Skills:

    consultant

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland