Head of Quality Assurance and Regulatory Affairs

Job Purpose (Role Definition): The Head of Quality Assurance and Regulatory Affairs will manage the Quality Assurance and Regulatory Affairs function, is appointed as the person responsible for regulatory compliance ensuring that the business meets the requirements of the MDR and serves as the Management Representative. The position is responsible for developing, implementing, maintaining and promoting the Quality Assurance and Regulatory Affairs strategy and providing leadership to the Regulatory and Quality Assurance functions, driving a quality and regulatory culture and ensuring that all staff are aware of the policies and procedures and the need to adhere to them.

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• Act as Management Representative.
  
• Act as the key liaison with the Authorised Person under the European Union Medical Device Regulation.
  
• Ensure that processes needed for the Quality Management Systems are documented in accordance with MDSAP and ISO 13485 standard.
  
• Report to Chief Executive Officer on the effectiveness of the Quality Management Systems and any needs for improvements.
  
• Promote awareness of applicable regulatory requirements and Quality Management Systems requirements.
  
• Support the preparation of global regulatory strategies for the registration of new and modified products and to implement the regulatory project plan, including applicable regulatory submission schedule deliverables.
  
• Develop, implement, maintain, and promote Quality Assurance strategy.
  
• Raise awareness and advise on compliance routes to support new product development.
  
• Ensure compliance to all applicable standards, regulations and internal procedures by proactively interpreting Quality and regulatory requirements and devising and implementing solutions to support the maintenance and enhancement of Quality Management Systems and regulatory documentation.
  
• Communicate with customers, notified bodies and other regulatory bodies to address Quality Assurance, Quality Management Systems and Regulatory Affairs issues and accreditations.
  
• Responsible for the overall compliance and delivery of Internal and External Audits, CAPA, Management Review and External Audits.
  
• Liaise with competent authorities and regulatory authorities on issues with patient safety for all products.
  
• Ensure that Vigilance and PMS processes needed for the Quality Management Systems within the Group are documented in accordance with MDSAP and ISO 13485 standard.
  
• Oversee the Complaint handling activities, ensuring all KPI's are met including complaint investigations and regulatory reporting timelines.
  
• Support the promotion of supplier and manufacturing quality awareness of applicable quality requirements and Quality Management System requirements.
  
• Responsible for the CAPA process management.
  
• Oversee the Nonconformity process.
  

Quality Assurance and Regulatory Affairs team.

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• Five years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
  
• Proven leadership in Quality Assurance and Regulatory Affairs within medical devices.
  
• A demonstrable strong working knowledge and experience of applying medical device standards and regulations within the medical device industry, in particular ISO 60601 series.
  
• Experience in liaising with Notified bodies, Certification Bodies and Competent Authorities.
  
• Experience of development of new products from initial concept to commercialisation.
  
• A track record of developing and executing global regulatory strategies that align with business needs.
  
• Experience managing CE marking and FDA approval processes.
  
• Experience and demonstrated performance working with medical device quality management and/or regulatory affairs, in particular software medical device standards.
  
• Experience working across different regulatory markets; EU, US and UK and any other relevant markets.
  
• Good knowledge of ISO 13485 and MDSAP.
  
• Good knowledge of ISO 60601 series.
  

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• MDR Certification.
  
• Internal Audit Certification.
  

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• A demonstrable and broad understanding of medical device quality assurance and regulatory affairs.
  
• The ability to interpret regulatory and standard requirements to ensure that implications for users and processes are clear.
  
• The ability to learn quickly and establish a high degree of regulatory and quality knowledge.
  
• The ability to engage and deliver compelling presentations to a varied audience and communicate and present a technical subject matter in an understandable, coherent manner.
  
• The ability to engage, inspire and manage subordinate staff to achieve the same levels of excellence expected of yourself.
  
• Excellent communication skills, flexible attitude and capable of multi-tasking and working to tight deadlines and under pressure.
  
• The ability to get on with and to influence people both internally and externally and to achieve objectives.
  
• Clear thinker, who can work independently and show leadership in managing and undertaking activities.
  
• Knowledgeable of, and sympathetic to, the commercial and business aspects of any transaction.