ISO13485 & MDR Auditor/Assessor

About us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About the role • Conduct audits and assessments in accordance with ISO13485, MDSAP, MDR based on the directive, regulation, harmonized standards and other applicable regulatory requirement following DNV’s accredited certification program and procedure. • Ensure independent and ethical of all auditing activities, upholding DNV’s values of integrity and impartiality. • Contribute to continuous improvement efforts by identifying and driving enhancements in audit processes, information management, and service delivery across teams. • Plan and deliver client projects such as assessments, gap analyses, training workshops, and other consultancy activities as assigned. • Maintain qualification and registration as a Lead Auditor/Assessor with DNV and relevant regulatory authorities. • Perform additional duties as assigned by the line manager to support team and business objectives. About you • Relevant Bachelor or higher degree related to medical science and medical device area. Core disciplines: biology or microbiology; biomechanical engineering; chemistry or biochemistry, medicine and clinic practice; computer and software technology; electrical, electronic, mechanical or bioengineering. etc. • Minimum 4 years of hands-on experience in the design, manufacturing, testing, or clinical use of medical devices within industry, laboratory, or hospital environments. Prefer product group: MDN1206 non-active ophthalmologic device, MDN1201 non-active deice for anaesthesia, emergency and intensive care, MDN1202 non-active device for administration, channelling and removal od substances, including dialysis. • High customer focus and service orientation • Strong communication and interpersonal skills • Proven ability to work collaboratively in teams and across functions • Self-motivated with strong commitment to continuous learning and development • Fluency in both written and spoken English is required