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Job Details

Regulatory Affairs Manager

Company: Hobson Prior
Location: Belgium
Reference: PV438573
Closing Date: 23 Jan 17
Type: Permanent
Salary (£): On Application
Benefits: €75,000

Job Summary:

Looking for a new opportunity in 2017?


Looking for a new opportunity in 2017? 



I am representing a world leader in innovative implant-based dental restorations – from single-tooth to fully edentulous indications near the Brussels area. 



You are responsible for all Regulatory Affairs deliverables linked to the management of new product development and Life Cycle Management activities with focus on software products and on Regulatory Affairs compliance projects.
You will be responsible for developing and executing regulatory strategies for assigned projects while focusing on the main markets, i.e. EU, US, CAN and AUS. 
You will be responsible for monitoring submission timelines and timely responses to requests by notified bodies or competent authorities. 
You will monitor legislative environment in main markets, i.e. EU, US, CAN and AUS and define and maintain an overview of the regulatory requirements and changes in the areas if applicable.
You will assess, approve and release communication material (instructions for use, leaflets, brochures). 
You will train and assist other departments to ensure continued compliance and timely market release

Master with a technical or scientific background
Minimum 3 to 5 years’ experience in regulatory affairs within the Medical Device Industry, preferably Software
You have knowledge of medical device legislation EU ,US, AUS and CAN 
You have good knowledge of quality system requirements such as ISO 13485 and FDA’s 21 CFR Part 820
You have good knowledge of software development requirements (IEC 62304 and IEC 62366) 
You are highly organized and able to work under strict timelines
Excellent communication skills in English (written/oral), further languages are an advantage

This is an excellent opportunity across a varied product range near Antwerp, Belgium.

For more information, please email me at or call me on +44 (0) 333 577 7578





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Contact Information:

Address:  Hobson Prior Europe GmbH
D4 Platz 3
6039 Root Längenbold
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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