Director of International QARA

We are working with a global multi award winning organisation who are seeking a Director of International Quality and Regulatory Affairs on a full-time permanent basis. You will promote and adhere to the company values of quality and compliance by Managing and overseeing all aspects of the QARA functions at multiple international sites by setting, directing, and overseeing policies on quality standards and regulatory compliance. You will be Interpreting new quality and regulatory requirements and trends as they relate to all operations, supporting and managing the relationship with external regulatory agencies. You will be responsible for guiding others within the organisation on quality management system and regulatory basics, ensuring understanding and compliance with updated requirements including EU Medical Device Regulations.

What you can expect

• Highly competitive salary and 20% bonus – disclosed on application
• Full time/ Permanent/ Hybrid role – offering the options to be based at multiple site locations across the UK, EUR and US/Global entities
• Medical Cover
• 3x basic salary life assurance cover
• Enhance employer pension contributions
• 24 days paid holiday

What we are looking for:

• Practise in medical device industry at least 15 years coupled with a University degree
• Thorough knowledge of EU, UK, and US medical device regulations, as well as ISO13485 and ISO 14971
• Effective QARA leader with a demonstrated ability to build, lead, and train a team of QARA professionals at multiple sites
• Ability to work with cross-functional partners to drive a culture of compliance
• Ability undertake routine International business travel
• Understanding of statistical analysis, root cause analysis, and the CAPA process
• Key Competencies, demonstrates ownership and accountability, with the ability to plan, execute, control and deliver.
• Communicate effectively, Team-orientated personality with the ability to lead and influence others effectively while creating and maintaining a positive environment
• Understanding of change management, conflict resolution and team dynamics, with ability to identify project and business risks and create mitigation strategies

What you will be doing:

• Build, lead and develop a team of QA and RA personnel focused on local and global compliance
• Contribute to and drive the global strategies for QARA and QMS alignment
• Work with leaders across the business to develop strategies and plans to fulfill the mission and goals of the business while maintaining compliance with quality standards and regulatory requirements
• Practice and mentor others to approach situations with a risk based approach
• Drive a culture of compliance through influence, relationships, and partnership with cross-functional leaders
• Apply various principles and techniques for developing and organising teams and leading quality initiatives and continuous improvement
• Facilitate meetings and aspects of projects. Assist in working through resistance to change and improvement
• Prepare or assist with the preparation of regulatory submissions including, but not limited to: 510(k), PMA, IDE, IND, BLA, NDA, CE Marking, applications.
• Prepare or assist with the preparation of Clinical Evaluation Reports with input from scientists and clinicians.
• Review documentation, prepare a gap analysis and write documentation to fill those gaps for regulatory submissions.
• Submit and maintain regulatory documents as required and Liaise with external organisations regarding regulatory matters
• Support product development processes and programs
• Perform, and teach others to perform, root cause analysis of identified issues including identification of appropriate corrective and preventive action
• Ensure effective implementation and maintenance of Quality System appropriate to the products manufactured by and for the company and compliant with the relevant requirements of FDA Quality System Regulations (21 CFR 820), ISO 13485, EU, UK Medical Device Regulation at multiple locations/sites
• Ensure the quality of the company products through the establishment, monitoring, and enforcement of a Quality Management System in compliance ISO 13485EU, UK Medical Device Regulation and 21CFR820 requirements
• Review documentation, including technical documentation, to ensure compliance with the relevant requirements of FDA Quality System Regulations (21 CFR 820), ISO 13485, EU, UK Medical Device Regulations
• Training of International QARA personnel
• Perform formal and informal audits as necessary, providing and supporting /leading regulatory audits as necessary

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