Assessment & Surveillance Manager
On behalf of my client, I am recruiting for an Assessment & Surveillance Manager.
The successful candidate will work as part of the Assessment & Surveillance section in the Medical Devices department; and will be responsible for coordination and management of all reactive and proactive activities relating to all medical device and in-vitro diagnostic device vigilance and market surveillance issues. This role will report to the Director of Medical Devices.
- Coordination and management of all reactive and proactive activities relating to all medical device and in-vitro diagnostic device vigilance and market surveillance issues, minimising risk to public health and ensuring compliance to relevant legislation.
- Designation and ongoing oversight of the performance of notified bodies for medical devices and in-vitro diagnostic devices.
- Assessment of technical and regulatory aspects of medical device and in-vitro diagnostic device technologies.
- Development of assessment team capabilities and expertise in line with departmental needs and regulatory/technological change.
- Development of assessment activities relating to growing and newly emerging technology areas, such as in-vitro diagnostics, device-drug combination products and digital technologies.
- Manage and develop the Assessment & Surveillance section and processes.
- Lead on complex technical issues and achieve required levels of performance and resourcing.
- Lead development of the team’s activities and capabilities, and to respond effectively to changes in the internal and external environment.
- A minimum of 5 years’ relevant experience in a research, healthcare, industry or regulatory environment.
- Experience in the assessment and decision making on health product issues.
- Minimum of three years of experience in the management of a multi-disciplinary team(s)
- Detailed knowledge and experience of EU and national legislation relating to the regulatory requirements for medical devices.
- A strong personal work ethos and a proven ability to manage high work throughputs and manage deadlines.
- An ability to adapt to changing conditions and display ability to generate effective and pragmatic solutions to new situations and problems, both strategic and operational.
- Be a self-starter, capable of excellent communication, negotiation and decision making; along with being an excellent motivator.
- In addition, the ideal candidate will also have one or more of the following:
- A relevant post graduate qualification in a scientific, legal or managerial discipline.
- Experience of regular high-level representation of organisational/national positions at National/European level.
- A strong customer service focus and commercial awareness with a proven track record in delivering performance.
- Experience of working collaboratively with cross-organisational teams in a solution focussed manner.
- A proven record in connecting with leadership teams to support, influence and provide expert advice.
If you are interested in applying for this role, please call Ciara on +353 1 2784671 or email email@example.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com