Executive Director Regulatory Affairs

Proclinical is working with a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. This CRO is seeking an Executive Director Regulatory Affairs - Medical Devices to be based in the Netherlands on a permanent basis.

This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Job Responsibilities:

• Provide expert strategic regulatory leadership to project teams across therapeutic areas and all phases of medical device development
• Lead Authorized Representative services in accordance with current European Union expectation
• Oversee staff and process in planning, preparation and delivery of regulatory submissions to domestic and international regulatory agencies and notified bodies.
• Identify project regulatory risks and provide innovative regulatory solutions to mitigate
• Collaborate with Global Regulatory Affairs colleagues to develop robust global regulatory approval and device development strategies
• Lead interactions and manage relationships with domestic and international regulatory agencies through frequent dialogue and scientific credibility.
• Provide expert regulatory and scientific review of core technical documents
• Maintain and train on up-to-date regulatory requirements, guidance and science
• Supervise, develop, and mentor regulatory, clinical and medical staff, as necessary or required
• Contribute to development of standard operating procedures and best working practices for organization
• Represent department/functional area in Business Development, including participation in general capabilities and bid defense meetings; and
• May be responsible for other projects and responsibilities as assigned.

Skills and Requirement:

• Bachelor's Degree in a related field; advanced degree highly preferred (M.D., Pharm.D, Ph.D.); life sciences degrees preferred
• A minimum of 10 years of Regulatory Affairs experience in the device industry;
• Broad experience of working with Class I, II, III and IV devices, specific experience with in vitro diagnostics and/or companion diagnostics advantageous;
• Prior experience and ability to develop technical documentation associated with clinical investigation of medical devices;
• Prior experience and ability to develop technical documentation associated with registration/CE marking of medical devices;
• Prior experience of managing authorised representative services;
• Ability to provide strategic regulatory input to development of medical devices;
• Prior experience of managing and leading a team of medical device professionals;
• Established relationships with key international regulatory agencies and European notified bodies;
• Experience working in a small, global company is preferred;
• Strong computer skills, project management skills, and a high attention to detail;
• Strong communication skills (both written and oral).
• This position may require supervision of junior level staff

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.