Company: Clinical Professionals Ltd
Closing Date: 09 Apr 17
Type: Full Time
Salary (£): On Application
Regulatory Affairs Consultant Job type: Full-time, permanent: Switzerland A unique career opportunity has arisen at Regulatory Professionals. We are working with one of the worlds most established and well-respected medical device manufacturers
Regulatory Affairs Consultant
Job type: Full-time, permanent
A unique career opportunity has arisen at Regulatory Professionals. We are working with one of the worlds most established and well-respected medical device manufacturers, with sites across the EMEA and the US. Our client is now looking for an experienced Regulatory Affairs Consultant to join their operations in Switzerland.
University Degree (BSc) or equivalent in life sciences, technical (engineering) or related field
Must have 3-5 years medical device industry experience
Must have experience with developing, coordinating, preparing and maintaining US medical device submissions such as 510Ks, PMAs, IDEs and applicable supplements
Good command of English both verbal and written, German is a plus
Supporting the activities for CE marking and international registrations of products and renewals of product licenses
Supporting of the submissions to international authorities (compile required documentation)
Working with the Regulatory Affairs personnel to obtain Certificates of Products for Export or other applicable export notifications from Swissmedic
Supporting of the Renewal of product licenses Internationally
Obtaining the notarizations, legalizations and other official documents
Interacting in a diverse environment, working with individuals in different geographies and countries
Medical devices; medical technology; diagnostics; Regulatory; RA; Consultant; Consultancy; biotechnology; affairs; regulatory affairs; Specialist; officer; manager; VP; director; 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; Switzerland; Austria;
In the event that you do not feel that this is the right role for you, please do not hesitate to forward these details on as we have a generous referral scheme in place.
Clinical Professionals UK
33 Blagrave Street
|Tel:||0044 118 959 4990|
|Fax:||0044 118 956 0607|
|Website:||Visit Our Web Site|
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