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Job Details

Regulatory Affairs Manager - no direct reports - will consider Senior Associate - Belgium

Company: Mosaic Regulatory Solutions
Location: Belgium
Reference: 7433332
Closing Date: 30 Dec 16
Type: Permanent
Salary (£): On Application
Benefits: Excellent

Job Summary:

To apply for this Regulatory Affairs Manager Medical Devices please give me a call on 07951 082482 or send your CV in the strictest consideration: julie@mosaicrecruitment.co.uk

Requirements:

Role :Quality Assurance Manager Medical Devices
 Location: Belgium

Salary - Negotiable

.


Main Objectives

 
To ensure compliance with ISO13485, ISO14971 and other harmonized standards
To ensure compliance with MDD directives & other regulatory requirements
To lead for new or changing product developments
To act as quality assurance lead for establishing subcontractor oversight of manufacturing sites

 

Main duties and responsibilities
Establish and Maintain the ISO13485 Quality Management System
Draft quality assurance policies and procedures
Key role in interpreting and implementing quality assurance standards
Audit manufacturing sites and establish and maintain quality agreements with manufacturing sites
Assist in performing internal audits, supplier audits and customer audits
Report and follow-up of corrective / preventive actions
Provide input to risk management plan and risk management file in line with ISO14971
Provide input for analysis of data and/or management review
Ensure adherence to critical procedures and compliance to requirements for record retention
Evaluate audit findings and implement appropriate corrective actions
Identify training needs and organize training interventions to meet quality standards
Providing quality expertise to various departments.

 

Minimum Qualification and Experience:
3rd Level Qualification in Science. ( Chemistry, Biochemistry, or related science discipline)
Minimum 3 years of experience in Quality/Technical support within a Healthcare Company
Experience with substance based medical devices is a plus

 

Person Profile:
Attention for detail
Self-motivated, flexible and open to changing requirements
Highly driven with enthusiasm to meet requirements and cope under demanding pressure
The ability to work autonomously and have good problem solving skills
An innovative frame of mind – open to applying creative techniques to find a solution


Key skills / key skills: regulatory , regulatory affairs , RA , regulatory affairs jobs , Reg Affairs , Regulatory Affairs Manager , Medical Devices , Belgium

Apply for this job: Regulatory Affairs Manager - no direct reports - will consider Senior Associate - Belgium

Contact Information:

Address:  Mosaic Regulatory Solutions Ltd
London
SE10
England
Tel:  0208 305 9733
Website:  Visit Our Web Site

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