The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Medical Device, Postmarket Surveillance, Quality/Risk Management, Regulatory Compliance
2 Year Degree
We are looking for a Quality & Regulatory Affairs Consultant to join our multidisciplinary team. You’ll be working on QMS, ISO and IEC documentation for CE marking and FDA submissions for cutting edge health technology, including artificial intelligence, for a range of international clients.
You’ll be joining a dedicated and highly qualified multi-disciplinary team of professionals and supporting a wide variety of international health technology businesses with your deep expertise in quality assurance and regulatory affairs. We offer fully remote working with flexible hours to suit your needs.
Full-time / part-time remote working (UK-based) as part of a decentralised team, with occasional travel
As a QRA consultant you will participate in medical device projects contributing to quality assurance and regulatory affairs deliverables for our clients, enabling them to take cutting edge health technology to market. The role will report to the Senior Consultant for Regulatory Affairs, and involve collaboration with company directors, clinical and technical consultants as well as international clients.
To assist the senior consultants by taking an active role in quality assurance and regulatory client projects (CE, MDSAP and FDA)
Reviewing client quality management system and technical documentation
Providing gap analysis against applicable EU and global regulatory requirements and standards
To share the workload of planning, executing and reporting client audits
Participate in client meetings, and prepare minutes and summaries of discussions regarding complex regulatory issues
Key Performance Indicators
Timely and diligent completion of allocated tasks
Performance and reporting of tasks to agreed standards
Proactive management of workload
Prompt and diligent resolution of assigned issues
Minimum requirements (candidates who cannot meet these requirements will be automatically screened out).
A minimum of 2 years experience of working in the medical device industry, ideally with some experience of software as a medical device (SaMD) or experience as an internal (first-party) or supplier (second-party) auditor
Experience in definition or audit of QMS procedures per ISO 13485
Experience or understanding of relevant ISO standards applicable to medical devices, health software, risk management and security (e.g. ISO 62304, ISO 14155, ISO 14971, ISO 27001)
Experience of using issue management and/ or customer relationship management (CRM) systems
Education at least to first degree or equivalent level
Skilled in the use of Microsoft Office and/ or Google G-suite applications (Word, Excel, PowerPoint and/ or Docs, Sheets, Slides)
Experience in working in a project-based environment with hours tracking and reporting
Ability and willingness for occasional domestic and international travel
Telecommuting is allowed.
Additional Salary Information: We will consider full time salary after 3 months probation as a contractor
Internal Number: 1
About Hardian Health
Hardian Health is a niche digital consultancy focussed on delivering novel and innovative technology into the front-line of clinical care through expert clinical, regulatory intellectual property, health economics and investment advisory services.
We work remotely and flexibly, and we stay up-to-date with the current trends in health technology.