B-Secur is looking for a talented, driven QA/RA Manager to join its team.
The QA/RA Manager is responsible for global regulatory affairs and quality assurance activities related to B-Secur’s Medical Device software products.
The QA/RA Manager is also responsible for advising and consulting with stakeholders about compliance with applicable FDA regulations, MHRA regulations, and other applicable standards. The QA/RA Manager will research, recommend, and implement best practices, and contribute to both the strategic and operational functions of the company.
- Ensure that quality system requirements are effectively established and maintained in accordance with all applicable medical device regulations, including QSR, ISO 13485, and other standards
- Maintain FDA and MHRA regulatory compliance for B-Secur software products, including registrations, listings, license amendments, 510(k) submissions, letters to file, labeling, UDI, and other requirements
- Provide leadership, guidance, and oversight to software product teams, and other employees with responsibilities related to regulated products
- Create and maintain regular lines of communication with teams to promote quality awareness, regulatory partnership, and harmonisation of quality processes
- Collaborate with HRD manager to develop, implement, monitor, and track standardised quality training for employees
- Conduct internal audits and provide guidance regarding best practices and continuous improvement
- Promote audit readiness, prepare teams for audits by external bodies, and facilitate audits as needed
- Support monitoring, measurement, and effectiveness of the B-Secur quality systems to continuously improve performance
- Partner with relevant teams on the execution of CAPA plans, tracking and verifying that deficiencies are corrected
- Work with the COO to respond to regulatory body enforcement inquiries by FDA, MHRA, or other responsible bodies
- Maintain expert current knowledge of applicable regulations, legislation, best practices, and guidelines related to QA/RA, monitor changes to applicable laws and regulations, identify impact to the business, and in collaboration with other stakeholders, develop response strategies and/or a work plan and complete according to deadline
- Manage key quality and regulatory affairs initiatives to drive continuous improvement
- Provide consultative guidance to B-Secur leadership, technical teams and other stakeholders of QA/RA issues
- Management of vendors as needed
- Other duties as assigned
- Initiative: Ability to work un-supervised, self motivated and committed to task completion
- Excellent communication: clear, concise written and verbal communication with strong inter
- personal skills
- Continuous improvement: Ability and desire to learn, develop and improve your own work
- Bachelor s degree
- A minimum of 5+ years of experience in the development, implementation, and maintenance of a quality management system, preferably in the context of software development
- Experience preparing FDA submissions, license applications, registrations and other product approval documentation and demonstrated knowledge of applicable requirements and practices
- Broad knowledge of medical device regulations (e. g. QSR, ISO 13485, etc)
This is an exciting opportunity to join a dynamic expanding company within a fast paced market. To find out more about the life at B-Secur, take a read of our latest interviews to meet the people behind the brand.
The B-Secur team are based in Belfast. This role will be based in Belfast, it may be necessary to visit other locations.