Company: Regulatory Professionals
Closing Date: 05 Jan 17
Type: Full Time
Salary (£): On Application
Regulatory Affairs Specialist. My client is a Global leader in the manufacturing of Ventilation systems, a market leader in the supply of intelligent and innovative ventilation systems for a wide variety of patient populations, applications, and environments, with their headquarters based in Switzerland.
Regulatory Affairs Specialist
My client is a Global leader in the manufacturing of Ventilation systems, a market leader in the supply of intelligent and innovative ventilation systems for a wide variety of patient populations, applications, and environments, with their headquarters based in Switzerland. They are looking for a Quality & Regulatory Affairs Engineer to join their operations based in the swiss canton of Graubünden.
Care of the product managers during the entire life cycle of the products in regulatory terms and to ensure that the technical documentation of the products complies with the European requirements for medical products
Responsible representation of the quality aspects and quality regulations as well as the normative and legal requirements, as well as communication of new regulatory requirements and support for the implementation
Execution of reviews
Communication with external test institutes
Preparation and execution of tests
Support of risk analysis
Support the Vigilance team
Support for the international approval according to the internal specification
The Ideal Candidate:
Studies in the natural sciences, electrotechnical or medical fields or completed vocational training plus at least 5 years of practical experience and additional professional development (eg master, technician, specialist diploma)
Experience in Regulatory Affairs / Quality is an advantage
Knowledge IEC 60601-1 series advantage
Experience in international approvals for medical devices, especially 510 (k) and Health Canada
Experience in quality management, development, testing and production of medical products
Experience in the field of vigilance is an advantage
Fluent in German and English
Medical devices; medical technology; diagnostics; Regulatory; RA; Consultant; Consultancy; biotechnology; affairs; regulatory affairs; Specialist; officer; manager; ; Germany; English; German; MDD; compliance; FDA; 510(k); 21; CFR; 820; 14971; 13485; Quality; Risk; Management; CE; Marking; CE mark; dossier; Notified body; IVD; In Vitro Diagnostic; IVD; EMEA; Americas; APAC;
3rd floor 33 Blagrave Street Reading
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