Our client is a leading designer, developer and manufacturer of medical technologies with a strong global presence. In order to continue their growth and meet strategic objectives, we have been tasked with identifying and recruiting a highly-skilled VP QARA to strengthen the team in the UK.

The successful candidate will be responsible for managing the company's QARA department and all Quality and Regulatory processes on a global scale.

The main tasks include:

• Development of regulatory strategies for life cycle management and expansion of manufacturing
• Preparation of the registration packages and responses to deficiency letters
• Effective communication with regulators to negotiate the requirements of the submitted data and delivery times
• Be the primary contact during quality and regulatory inspections and be responsible for managing escalated customer issues and driving continuous improvement activities
• Develop and implement a clear customer-centric vision for Quality and Regulatory.  Manage, coach and communicate the vision to internal and external leaders across the organization.
• Ensure assessment of changes in manufacturing for regulatory effects and compliance with applicable regulations
• Awareness of global regulatory requirements and laws
• Carrying out the necessary tasks of personnel management and supporting management
• Conduct due diligence to support the further development of the corporate strategy

Key qualifications and experience required:

• Degree in manufacturing, engineering, sciences, quality or other technical/quantitative fields, ideally MBA or other advanced degrees
• At least 10 years of relevant experience within the Medical Devices field and at least 5 years of experience on a senior position
• Proven knowledge and experience in U.S. FDA drug regulatory requirements, ISO, QSR, MDR, GMP, GLP, GCP, HIPAA.  
• Deep knowledge in all global regulatory compliance aspects of medical devices: pre-market, commercial, post-market, and regulatory
• Excellent computer and presentation skills and full business proficiency in English