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Job Details

Medical Device - RA Manager

Company: Barrington James Clinical
Location:
Reference: MDRA-German
Closing Date: 23 Feb 18
Type: Permanent
Salary (£): On Application
Benefits:

Job Summary:

For more information, please call Carlos Biggemann on +44(0)1293 776644 or email cbiggemann@barringtonjames.com

Requirements:

DESCRIPTION

- Ensuring compliance with regulatory requirements (MDD, FDA, PAL, CFDA) in collaboration with the development departments in the product development process

- Development of registration strategies for medical devices

- Participation and Collaboration in Design Reviews

- Coordination of all necessary regulatory affairs activities, in particular the approval and maintenance thereof, as well as the coordination with the respective specialist departments, suppliers and notified bodies

- Preparation of documentation for product approvals

- Examination and approval of development and accompanying documents from the regulatory point of view

 

PROFILES

- University degree (university / university of applied sciences) with a technical orientation or comparable work experience in the field of regulatory affairs

- Knowledge of international approval requirements

- Knowledge of the relevant product standards (IEC 60601, 62304, etc.)

- Experience in project management

- Strong communication skills

- English fluently in speech and writing

Apply for this job: Medical Device - RA Manager

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
RH6 7AF
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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