Quality and Regulatory Officer - United Kingdom
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Main Duties/Responsibilities and Knowledge/Skills Requirements/Authorities
- To provide operational technical support for the Head of Regulatory Affairs in particular regarding medical device regulatory affairs at both company and group level.
- To act as ISO Quality system representative to ensure compliance with ISO 13485 & ISO 9001 systems in conjunction with QEHS Department.
- Efficient administration and management of regulatory Technical files to maintain CE Marking.
- To develop and deliver strategy to meet the requirements of the new Medical Device and IVD Regulations.
- To provide a high level of customer service as first point of contact/key interface with externals on technical queries, complaints, recalls/FSCA, vigilance incl post-marketing surveillance and quality issues for medical devices and pharmaceuticals.
- To perform internal and external auditing as assigned in annual schedule including to ISO 9001, 13485 requirements.
- Assistance with Group UK’s ISO 13485 quality management system including:
- monitoring, developing, reviewing and seeking approval for continuous improvements in ISO quality assurance policies and standard operating procedures
- Manage and optimize activities in line with the chosen strategy, regulatory requirements and agreed financial targets and resources.
- Manage and maintain good professional working relationships both internally and externally.
- Ensuring that the processes needed for the quality management systems are established, implemented and maintained
- Reporting to management on the performance of the quality management system and any need for improvement.
- Ensuring the promotion and awareness of customer requirements throughout the organisation
- To maintain and improve on current business ethical standards for Group (UK).
- Maintain knowledge of applicable legislation, guidelines, ISO standards and current industry practice that impact Quality and Regulatory Affairs for medical devices and pharmaceutical distribution.
Experience and Key Skills
- Regulatory experience in Medical Devices including technical file management
- Experience of working in an ISO 9001:2008 environment and ISO 13485:2015
- Experience of auditing to ISO 9001 and/or ISO 13485
- Lead Auditor qualification in quality assurance desirable
- Experience of regulatory body liaison e.g. the MHRA/HPRA/FDA
- Proven ability to work as part of a multi-functional team
- Highly effective problem solver, excellent communicator, both verbal and written
- Computer literate and clear & concise report writer
- Ability to produce results, prioritising objectives and scheduling work to make best use of time and resources
- A good understanding of commercial implications of role
- QMS software systems experience
- Ability to cope effectively with pressure and setbacks and maintain commitment in spite of opposition
- Proven ability and experience of working on own initiative, and to play a proactive role as part of the wide Quality and EHS team based in the group
- Flexibility to travel within the group to subsidiary sites if required