Assessment & Surveillance Manager

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.

Key Responsibilities:

• 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.

Qualifications/Experience:

• 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 focused manner.
• A proven record in connecting with leadership teams to support, influence and provide expert advice.