We are currently working on an exciting opportunity with world renowned notified body. Who are seeking a Technical Specialist/Scheme Manager in the area of Active Devices to join their team. Reporting to the global head of active devices this role can be a home based role or office based globally.
To manage a portfolio of Medical Device CE marking clients.
Plan and deliver Technical File Assessments and Unannounced Audits in support of EC Certification
Manage client projects, acting as their primary contact and after satisfactory assessment make certification recommendations for CE certificate issue
Act as technical support to the commercial team when required
Provide in-house and external training in areas of expertise
Deliver Medical Device CE Technical File Assessment services from office, and on-site as a fully integrated member of the Active Devices Team
Perform Unannounced visits to medical device manufacturers globally as a technical expert
Support the Commercial Team as it grows the customer base worldwide
Delivery of all services within required timescales and to a high quality
Maintaining client satisfaction whilst continuing to meet ethical expectations
Performing in-house training
Maintain and expand competence in areas of technical expertise and Medical Devices certification
The jobholder will be a member of the Active Devices Team reporting to the Global Head, Active Devices and work as a colleague with other members of the Medical Devices Business Stream.
There is interface at all levels of management in client and regulatory organisations.
Some global travel is expected to perform technical assessments, unannounced visits and to attend relevant meetings and training.
BSc degree or PhD, or equivalent qualification, in a discipline relevant to medical device manufacture and use
4+ years of Medical Device experience in a technical capacity, preferably within product design, development and testing; manufacturing experience also advantageous.
Interpretation and applications of International and National standards for the design, manufacture and regulation of medical devices.
Understanding of Risk Management and FMEA of Electromedical Devices
Conceptual and analytical thinking, efficiency and results orientation
Ability to work independently with minimal supervision; self-motivated.
A team player good at relationship building internally and externally
Broad technical understanding of electromedical devices. Understanding of companies operating in these spaces and current industry trends.
Thorough knowledge of Medical Device regulation and Knowledge of QMS systems for medical devices would be advantageous.
English as a minimum.
James Cassidy | Tel: +353 (0) 1 5079250