Company: Regulatory Professionals
Closing Date: 12 Feb 17
Type: Full Time
Salary (£): On Application
Regulatory Affairs Manager I am working with a vibrant and exciting biotechnology company with offices based in the USA, Canada and Europe, specializing in the development and production of molecular diagnostics systems for detection of viruses
Regulatory Affairs Manager
I am working with a vibrant and exciting biotechnology company with offices based in the USA, Canada and Europe, specializing in the development and production of molecular diagnostics systems for detection of viruses, bacteria and parasites.
We are looking for a experienced Regulatory Affairs Manager to join their operations in Hamburg, Germany.
Development of licensing strategies and procedures in accordance with legal requirements and international guidelines
Consulting and monitoring of internal departments to ensure compliance with regulatory requirements at all stages of product development, in particular the development and adaptation of hardware and software for invitro diagnostics
Creation of documents for international approvals (e.g., Europe, Canada, USA, South America, Australia and Asia)
Assistance in the preparation and maintenance of the technical documentation
Assessment and evaluation of data and documents with regard to their suitability for authorization purposes
Communication with regulatory authorities
Support for cooperation and marketing partners in the approval of products in the respective countries
Independent research of updates and changes of national and international regulatory approvals
The Ideal Candidate:
Science or Engineering degree
At Least 2 years industry experience in current role within the field of regulatory affairs, admission of medical in the EU and USA
Strong knowledge of internal and external EU regulatory approvals and standards; EN ISO 13485, EN 62304, EN ISO 14971, EN 62366, FDA 21CFR820, IEC 60601, IEC 62304.
Very good knowledge of German and English, spoken and written
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
|Tel:||+44 (0)118 9522 797|
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