QA / RA Director - Medical Devices

South East England  ‐ Onsite
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Keywords

Description

  • Define and implement a global quality system that is fully compliance with CFR21 Part 820 and the US Medical Device Regulations, 93/42/EEC and subsequent amendments / New European Medical Device Regulations and International quality and regulatory standards including ISO13485 and ISO14971.
  • Implement an audit program to identify improvement opportunities and ultimately improve the effectiveness of the quality system.
  • Build and train the QA/RA team comprised of both internal and external resources to achieve quality objectives.
  • Serving as a member of the senior executive team which requires involvement in business-wide strategic planning, resource allocation, and performance management.
  • Lead the strategic quality and regulatory direction through:


- Establishing an annual Quality Plan

- Establishing and maintaining Product Regulatory Strategies

- Configuring and adapting the Quality Management System and Regulatory Technical.

- Documentation to maintain worldwide regulatory compliance.

Qualifications, skills & experience;
  • An effective leader, strong leadership, management and mentoring skills, team-oriented.
  • Minimum 10+ years of experience in the medical device industry with at least 5 years of supervising professional staff and front-line managers.
  • Experience in managing a multi-disciplined compliance organization, including quality and relevant regulatory experience.
  • Ability to integrate regulatory expertise with business objectives and effectively communicate, coordinate and interact with upper management, managers and personnel within other departments.
  • Thorough understanding of US and international regulatory requirements and standards for development, validation, manufacture, marketing and distribution of medical devices


My client has slots arranged for interview and is looking to move quickly on this so if you would like to hear more then please send your CV and I will be in touch shortly.
Start date
08/2014
Duration
ASAP
From
Real Staffing
Published at
13.08.2014
Project ID:
757410
Contract type
Permanent
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