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Job Details

Senior Regulatory Affairs Manager

Company: Hobson Prior
Location: Hessen
Reference: MK467430
Closing Date: 24 Dec 17
Type: Permanent
Salary (£): On Application
Benefits: €80,000

Job Summary:

A multi national medical device company are offering the opportunity for an experience regulatory professional to work on class 2 active medical device. 

Requirements:

A multi national medical device company are offering the opportunity for an experience regulatory professional to work on class 2 active medical device. 

Role

  • You will be heavily involved on global registration of new cutting edge product and introducing the product within new markets. 
  • Types of activities you will typically involve in are: 510k and CE marking registrations, post marketing vigilance and surveillance of these products. Maintaining and improving the quality management system along with conducting internal and external audits. 
  • Helping to develop their risk management ISO 14971 processes in line with the new MDR. 
  • Assist with the regulatory strategy including new MDD/IVD directive changes
  • Reporting into the head of RA based on site

Experience

  • 4+ years of working within a regulatory position within the active medical device/medical device industry 
  • Experince with any global registration work is a must. Preference of a strong EU and US exposure.  
  • Previous experience within risk management handling and implementing of ISO 14971.

 

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Contact Information:

Address:  Hobson Prior Europe GmbH
D4 Platz 3
6039 Root Längenbold
Luzern
Switzerland
CH-6039
Switzerland
Tel:  t: +41 (0)41 455 25 60
Fax:  f: +41 (0)41 455 25 61
Website:  Visit Our Web Site

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