Company: Clinical Professionals Ltd
Closing Date: 05 Jan 17
Type: Full Time
Salary (£): On Application
Regulatory Affairs Program Lead Job type: Full-time, permanent. Germany A unique career opportunity has arisen at Regulatory Professionals. My client is one of the worlds most established and well-respected medical device manufacturers
Regulatory Affairs Program Lead
Job type: Full-time, permanent
A unique career opportunity has arisen at Regulatory Professionals. My client is 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 Program lead to join their operations in Germany.
The successful candidate will fulfil the following criteria:
*Having global Regulatory Affairs expertise for US; Asia Pacific; Latin American Countries and EU;
*Proven, high-level experience of the medical devices Regulatory sector Globally, Product registration; CE Marking and dossier submission;
*Knowledge of other applicable international Regulatory requirements (FDA, 510(k));
*Solid understanding of medical devices Class II to III and in-depth expertise in Orthopedics
*German language to a native-level standard, with fluent English language skills is required;
Following their selection, the successful candidate will responsible for the following areas:
*Represent regulatory affairs on product development teams by attending team meetings and providing the global regulatory plan, regulatory assessments and regulatory decisions
*Prepare regulatory documentation for clients devices, including Design Dossier, Technical file as well as IDE, 510(k) and PMA documentation for submission to the Food and Drug Administration (FDA). This includes the resolution of regulatory issues and questions from regulatory agencies and Notified Bodies during the pre-market product development phase
*Obtain Medical Device Licensing, Medical Device Establishment licensing, CE Marking and 510(k) clearance for Class I, Class II (a and b) and Class III medical devices in Europe;
*Obtain Regulatory approval for the marketing of devices across Classes I to III;
*Consulting on Regulatory Affairs matters pertaining to orthopedic devices;
*Provide expertise in MDD (Directive 93/42/EC), Quality requirements 21 CFR 820, ISO 13485 and Medical Device Risk Management ISO 14971.
Medical devices; medical technology; orthopedics; 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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