Medical Device Product Specialist

Proclinical currently has an excellent new opportunity for a Medical Devices Product Specialist to join a global organisation. The successful candidate will be primarily responsible for conducting EC Design Examination reviews of client's technical documentation for Class III Medical Devices (93/42/EEC) and/or Annex II List A IVD medical devices (98/79/EC). This role can be based across Europe and is a contract position.

Job Responsibilities:

• Ensure that reviews are technically sound and in compliance with all applicable regulations; standards; guidelines and Competent Authority expectations.
• Ensure that the highest level of service is provided through efficient service delivery and that customer requirement are met.
• Ensure adherence to company policies, procedures and processes.
• Ensure regulatory compliance of technical file reviews under applicable EU Medical Devices Directives and /or Regulations.
• Conduct reviews (primarily desk-based, but occasionally may be on site) in accordance with established procedures, maintaining a high standard of service delivery.
• Maintain personal competence and development in qualified specialist areas on an ongoing basis
• Project-manage reviews, as appropriate, to maximise efficiencies, enhance client satisfaction and ensure compliance with standards
• Within the individual's area(s) of expertise: Provide technical support, advice and staff training within the company; manage regulatory compliance and iii) develop understanding of clinical evaluation requirements
• Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business
• Provide accurate and timely reporting as required by line management to assist the planning and management of operations
• Ensure full compliance with the Company's Code of Integrity & Professional Conduct, and act in accordance with the company's UK's Equality & Diversity Policy and ensure others do so.
• At all times, adopt a safe behaviour by exercising due regard for the health and safety of yourself, colleagues and clients, in line with the Company's policies and procedures.

Skills and Requirements:

• Meet appropriate regulatory and Notified Body Code of Practice requirements for clinical expertise, EC Design examinations, technical file reviews and high risk invasive devices or IVD high risk devices.
• Must be able to demonstrate appropriate knowledge and technical expertise in the specialist area (e.g. cardiovascular or orthopaedic; high risk virology or blood grouping IVD testing etc) including relevant technologies and clinical applications
• Must have a detailed understanding of the relevant medical device regulations and international/harmonised standards for which audits/technical reviews are being undertaken (e.g. working knowledge of MEDDEV 2.7.1 rev 4)
• Working knowledge of appropriate compliance/auditing techniques
• Fluent in English and ability to write clear, concise and coherent technical reports
• Effective interpersonal skills; able to develop good working relationships with people at all levels
• Must be IT literate i.e. competent in the use of Office applications and preferably experience of using large and complex databases
• Willingness to learn and adapt to change - committed to continuous personal and professional development
• Extensive knowledge and experience of relevant regulations, standards and guidelines.
• 4 Years working experience with practical experience in the medical device / IVD sector
• Experience of reviewing technical files for high risk Class III devices and/or List A IVD's
• Training in relevant EU medical device directives and regulations, assessment and certification principles or equivalent
• Experience working in a technical capacity (e.g. performing assessment/ technical reviews) within a Medical Device Notified Body
• BSc degree or equivalent in the relevant medical/clinical sector or appropriate science subject
• Master's degree in a relevant area for medical devices / PhD in a relevant area for medical devices

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 Peter Duvall on +44 203 0789 542 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.