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Job Details

Regulatory Affairs Manager

Company: Regulatory Professionals
Location: Germany
Reference: J26436
Closing Date: 30 Dec 16
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

Regulatory Affairs Manager My client is a leading international manufacturer of high-quality speciality products in medical technology, with headquarters in Germany, they are looking for a Regulatory Affairs Manager to join their operations based in the Freiburg area.

Requirements:

Regulatory Affairs Manager

My client is a leading international manufacturer of high-quality speciality products in medical technology, with headquarters in Germany, they are looking for a Regulatory Affairs Manager to join their operations based in the Freiburg area.

Responsibilities:
Identifying the regulatory requirements for approval in the US
throughout the project and systematic approach in the approval
Responsible handling of regulatory and business requirements
Close collaboration with the developer teams
Monitoring of normative requirements in the development process
Targeted training in the development of normative aspects
Early information about changes to the approval, standards and their impact on our products
Contact for both American and European teams

The Ideal Candidate:
Engineering studies or adequate training
Min. Two years of professional experience in Regulatory Affairs / Quality Management
Knowledge in the field of approval in the US
Reliable appearance in global project structures
Expertise in the field of medical-technical products
Communicative and analytical competence
Independent and structured work
Very good knowledge of English and German



Key words
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;

Apply for this job: Regulatory Affairs Manager

Contact Information:

Address:  UK Office
3rd floor 33 Blagrave Street Reading
RG1 1LG
England
Tel:  +44 (0)118 9522 797
Website:  Visit Our Web Site

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