Regulatory Consultant (Medical Device)
Do you have experience of regulatory compliance in the medical device industry? Are you interested in making a transition to consulting and advising companies on their compliance requirements?
Our client is a regulatory consultancy specializing in compliance for companies in the medical sector. This is a global team seeking to add a junior level consultant in Northern Ireland. You will provide support to the senior management team to ensure client processes are in compliance with required global standards and that all necessary documentation is in place for submission of technical dossiers to global regulatory bodies.
This is an excellent opportunity to join a great team and there will be ample scope for growth and progression. You will learn from your fellow consultants and work with some fantastic clients, from start-ups to Multinationals, on a variety of projects
Core duties will include, but be limited to, the following:
o Contribute to the formulation and implementation of the short, medium and long term business strategies and the development of KPIs that allow for measurement of success.
o Support the work of the company in the provision of specialised clinical and regulatory assistance to client companies, ensuring expectations and interests are met.
o Research and prepare elements of regulatory submission documents on behalf of client companies, including but not limited to CTA`s, Study risk determination requests, IDE submissions, 510(k), PMA, CE Technical Files and Design Dossiers, PMDA Briefing Documents and Submissions etc.
o Assist wider team in the set-up, management & conduct of clinical investigations worldwide.
o Prepare audit reports and gap analyses on behalf of client companies.
o Work to manage and prioritise actions relevant to internal process development and client
o Contribute to the preparation of global clinical and regulatory guidance documents and white papers.
o As required, take advantage of professional networking opportunities in order to promote the company and its services to appropriate parties.
o Design and deliver formal client presentations, including proposed solutions.
o Undertake continuing professional development activity to ensure awareness of current quality and regulatory standards.
o Any other duties, within reason and capability, as determined by the Management.
As a successful applicant you must have:
o An honours degree in an engineering or scientific subject
o 5+ years medical device/IVD manufacturing industry experience
o Experience of risk management and CAPA systems
o Experience of developing quality management system documentation relevant to regulatory and/or clinical affairs
o Experience of leading global regulatory submissions (eg/FDA/Health Canada)
o Knowledge of regulatory requirements in emerging markets (eg. Asia/South America)
Alternatively you may instead have:
o 5+ years medical device/IVD R&D
o Knowledge of ISO 14155 and/or EN 13612 and its implementation to achieve and maintain device GCP compliance
o Working knowledge of 21 CFR Parts 812/312, 50, 54 and part 11 requirements or equivalent
o Knowledge of clinical data management requirements
o Experience of clinical risk management and site CAPA
o Knowledge and experience of conducting IRB/IEC
o Experience of developing clinical quality management system (QMS) documentation
Excellent interpersonal skills
o Excellent communication and presentation skills,
o Evidence of strong analytical and problem solving skills
o Strong approach to organisation and time-management
o Proven ability to achieve results while working independently and on own initiative
o Strong mathematical ability
o Proficient in the use of MS Suite including Powerpoint
This is an exciting opportunity and if you feel you meet the criteria please don`t hesitate to call Stephen Haslam at Brook Street on 02890 324548. Alternatively you can click on "Apply"