IVDR Assessor

You will be part of a leading expert organization specializing in assurance and risk management. With a commitment to safeguarding life, property, and the environment, you will play a crucial role in empowering customers and stakeholders with reliable insights to make confident decisions. Being a trusted entity for top global organizations, your expertise will contribute to advancing safety and performance, setting industry benchmarks, and innovating solutions to address global challenges. Your responsibilities will involve conducting audits and assessments related to In-Vitro Diagnostic Medical Devices. As an Assessor, you will perform assessments according to established procedures, ensure effective customer communication, and review Technical Files for specific products. Your role will also include completing projects related to IVDR procedures and making certification decisions within stipulated timeframes. In the role of an Auditor, you will be responsible for auditing manufacturers" quality management systems and suppliers/subcontractors when necessary. Conducting surveillance audits, maintaining strong customer relationships, and managing auditing teams efficiently will be key aspects of your job. Additionally, you will undertake projects related to IVDR procedures and contribute to certification recommendations within defined timelines. Required qualifications for Assessors and Auditors include a technical college degree in relevant areas such as Biology, Chemistry, Medical Technology, Human Physiology, Nursing, or related fields. Candidates must possess a minimum of 4 years of full-time work experience in the In-Vitro diagnostic medical device industry, academia, or hospital settings, with at least 2 years focused on device design, manufacturing, testing, or usage. Practical experience in quality management systems, production processes, and performance evaluation data related to In-Vitro diagnostic medical devices is essential. Preferred qualifications include a strong understanding of medical device management systems, standards, compliance auditing techniques, and risk management practices. Experience with Harmonized medical device standards, EN ISO 14971, and technical writing skills are advantageous for this role. Candidates with a Ph.D. in a relevant field related to in-vitro diagnostic medical devices may substitute work experience requirements with appropriate expertise. In addition to competitive compensation, you will enjoy flexible work arrangements, generous paid leaves, medical benefits, pension schemes, training assistance, and various additional benefits. The company values work-life balance, career development, and employee well-being, offering a supportive and rewarding work environment. Join us in our mission to drive trust, transparency, and sustainable results in the assurance industry, contributing to global transformations and making a positive impact on society.,