Company: Regulatory Professionals
Closing Date: 30 Dec 16
Type: Full Time
Salary (£): On Application
Quality Engineer & Regulatory Affairs (w\m) 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.
Quality Engineer & Regulatory Affairs (w\m)
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.
Respond to regulatory authorities' requests for additional Information.
Participate in product teams developing new products to define global regulatory requirements.
Interface with International Regulatory Affairs Team to support preparation of dossiers for registration for other international markets such as Japan, the Far East, Australia and Latin America.
Keep abreast of changes and proposed changes to the worldwide regulatory requirements related to our products and processes.
Assist in the development and maintenance of regulatory procedures to assure consistent, efficient and compliant regulatory processes.
Assist with compliance activities related to FDA regulations and ISO quality system Standards.
Develop, coordinate, prepare and maintain US medical device submissions such as 510ks, PMAs, IDEs and applicable supplements and annual reports and liaise with FDA reviewers as needed.
Develop, coordinate, prepare and maintain Canadian Class 2, 3 or 4 Device License submissions.
The Ideal Candidate:
Bachelor"e;s Degree is required, preferably in engineering or life sciences.
Minimum of 3 years regulatory affairs experience in the Medical Device industry is required.
Experience with 510(k) submission and/or PMAs.
Ability to work in small team environment, but also self- starter with ability to work independently is essential.
Must be able to meet deadlines and be detailed orientated.
Good planning and organization skills are a must.
Strong critical thinking and problem solving skills are preferred.
This placemenet will be managed by our Swiss Partner Sigma Management Services
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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