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Job Details

Regulatory Affairs Consultant

Company: Clinical Professionals Ltd
Location: Switzerland
Reference: J25967
Closing Date: 05 Jan 17
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

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

Requirements:

Regulatory Affairs Consultant
Salary: Competitive
Job type: Full-time, permanent
Location: 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, 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.

Eligibility
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

Key responsibilities
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

Key words
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.

Apply for this job: Regulatory Affairs Consultant

Contact Information:

Address:  Clinical Professionals UK
3rd Floor
33 Blagrave Street
Reading
Berkshire
RG1 1PW
England
Tel:  0044 118 959 4990
Fax:  0044 118 956 0607
Website:  Visit Our Web Site

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