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Job Details

Director of Quality and Regulatory Affairs (m/f)

Company: EPM Scientific
Location: Heilbronn
Reference: -
Closing Date: 24 Nov 17
Type: Permanent
Salary (£): 60,000 - 80,000
Benefits: Company car

Job Summary:

The CompanyMy client is a medtech manufacturer in the field of interventional cardiology and electrophysiology equipment with offices in Heilbronn (Germany) and Maastricht (Netherlands)....

Requirements:

The Company

My client is a medtech manufacturer in the field of interventional cardiology and electrophysiology equipment with offices in Heilbronn (Germany) and Maastricht (Netherlands). The company has 30 employees and with more than 1,000 systems installed worldwide and a successful market presence of more than 60 years. My client is synonymous with a solid partnership in the field of cardiology. They are looking for a Director of Quality and Regulatory Affairs for their main office in Heilbronn.

The Function

The director must establish strategic goals in quality and regulatory affairs and must define procedures that maximise quality and regulatory standards.  He/she will be directing development and manufacturing sites for quality and regulatory testing. He/she will develop strategies and implement programs to assure regulatory compliance and standards of quality and regulatory. As well as providing leadership and guidance on design for quality and regulatory to new product development staff. He/she reviews procedures of departments by recommending solutions to problems or changes in procedures, and maintains professional and technical knowledge by attending educational workshops reviewing professional publications. He/she must have oversight over company policy and system for notifiable events (vigilance system, MDR) globally.

Candidate Profile

  • Master’s degree in engineering or similar discipline.
  • Hands-on mentality.
  • Knowledge of ISO13485, 21 CFR 820 regulatory requirements.
  • Minimum 6 years’ experience in Quality Management systems.
  • Significant experience with notified bodies, audit procedures and problem-solving.
  • Ability to collaborate and communicate cross-culturally and cross-functionally.
  • Demonstrated leadership skills.
  • Willing to work in a small team (1 DR, 1-2 external consultants)
  • Willing to travel, including outside normal working hours 
    (approx. 20%).

Benefits

  • Pension scheme
  • Company car
  • Bonus

Kit.Agunbiade@empscientific.com

Or visit our website at;
https://www.phaidoninternational.com/epmscientific.aspx?gclid=CMbc4qW2n9YCFU217QodAeoFDw

 

 

 

 

 


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