Our client is one of the world's leading expert organizations in testing, inspection, and certification. The company works to achieve safety on the road, at work, and at home and is one of the largest expert organizations in the world with over 45.000 employees. For its medical device division, STANDBY Consultores
is recruiting a Medical Certification and Qualification Manager, working remotely within Europe.
The Medical Certification Training and Qualification Manager is responsible for planning and coordinating with the company’s different Regions the training and qualification of staff handling the certification of medical products. The training consists on establishing and maintaining a high level of knowledge on international and European certifications of medical products according to the applicable regulations. The role will include also execution of training when required as well as the assurance of the quality of training and its optimization to reduce the training and qualification period.
Essential Duties and Responsibilities
• To manage the demands, requirements and qualification standards with the Competent Authorities in order to lower them (whenever possible) and adapt the training plans and contents to such requirements, optimizing the effort of the staff subject of training.
• Develop training material, organize schedules, execute the training, provide logistical support to other training teams in the Regions and maintain training records.
• Partner with internal customers to assess and implement training needs for new and existing employees.
• Update training to ensure policy, regulatory, legal and system changes are incorporated in training curricula.
• Facilitate and execute learning through a variety of delivery methods including, among others, classroom instruction, virtual training and on-the-job coaching.
• Provide train-the-trainer sessions for internal subject matter experts.
• Maintain liaison with internal trainers and external training agencies.
• Support staff with filling the qualification sheets after fulfilling the required level.
• MSc degree in Engineering, Science, or healthcare-related field.
• A minimum of 8 years of experience in a relevant Life Science field.
• At least five years delivering training workshops in a public or private setting.
• Preferably, 4 years Notified Body auditor and/or file reviewer experience.
• Fluent in English.
• Interpretation and application of codes, regulations, and standards in the medical device industry.
• Quality systems planning and implementation.
• MDSAP, EU-MDR and/or ISO 13485:2016 auditing experience; CE Mark certification. Experience in file reviews for devices in a desirable large number of NBOG codes.
• QMS auditing and corrective action plans.
• Design control as well as process validation program development and implementation.
• Supplier management; Risk management.
• Effective Communicator.
• Positive – Can Do Attitude.
• Team Player.
• Extremely organized.
• High Spirited.
• Effective Listener.
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