Medical Device Assessors
hace 3 semanas
DNV is a global leader and innovator in inspection, verification, testing and certification services. Founded in 1864, DNV is recognized as the global benchmark in quality and integrity. We encourage new ideas, we welcome people who challenge the way we do things, and we will be 100% committed to helping you reach your full potential.
DNV Product Assurance AS is an accredited Certification Body and MDR approved Notified Body for Medical Devices and Hazardous Area Equipment. We provide global market access by testing and certifying the safety and quality of products and systems to international safety and quality standards and regulations. Our high professional standards and our sustainable approach guarantee you a forward-thinking work environment, within an organisation that invests in its employees, and is committed to providing you with continued development.
As part of our continued growth, we are looking to recruit technical and experienced Non-Active Medical Device Assessors and Lead Auditors throughout Europe. The successful candidates will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, MDD 93/42/EEC, MDR 745/2017 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.
Key Accountabilities
• Conduct assessments (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
• Conduct Technical File reviews specific for products being authorized.
• Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
• Complete specific projects in relation to medical device procedures, processes, systems and documentation as requested by the Medical Devices Operations Manager.
• If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements.
• Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards.
• A competitive compensation and benefit package
• DNV training and qualification program
• A professional community in a prestigious technological company
• Possibilities to work with interesting and challenging projects
• Access to an extensive competence network
DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity.
Position Qualifications:
Assessors and Auditors shall have a technical college degree in a relevant product or medical area, as described below.
Non-Active devices
• Biology or Microbiology
• Biomechanical Engineering
• Chemistry or Biochemistry
• Dentistry
• Human Physiology
• Materials or Biomaterials Science
• Medical Technology
• Medicine, Veterinary Medicine
• Nursing
• Pharmacy, Pharmacology, Toxicology
• Physics or Biophysics
• Physiology
In addition to a relevant educational degree, candidates must have a minimum 4 years’ work experience (full time) in a medical device related industry, with at least 2 of these years in the design, manufacturing, testing or use of the device in which they are qualified to Audit / Assess, and/or experience as an assessor in a notified body (full five technical documentation assessments).
As part of this work experience, risk management experience should be covered:
• Practical experience in conducting pre-clinical testing or assessing preclinical data with medical devices in one or more of the following areas such as biological safety, physical, chemical and microbiological characterization, stability, shelf life, performance and safety
A PhD in a relevant area for medical devices can substitute 3 years of work experience provided it includes 2 years’ experience in design, manufacture or testing.
To be considered for this role, you will have professional experience in a relevant field of healthcare products or related activities, for example:
• Work in medical devices industry or closely related industries (. pharmaceutical industry) in a research and development, manufacturing, quality management or regulatory affairs capacity
• Work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies
• Work in the application of device technology and its use in health care services and with patients
• Testing devices for compliance in accordance to the relevant national or international standards
• Conducting performance testing, evaluation studies or clinical trials of devices
In addition to the above you’ll also need to demonstrate the following;
• An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques
• Work experience in positions with significant QA Regulatory or management systems responsibility
• Experience with Harmonized medical device standards for active & non active medical devices
• Experience with Risk Management EN ISO 14971
• Experience with Sterilization techniques (such as ETO, Gamma, Steam, Dry Heat) and formal qualification desirable
• Medical device experience from auditing/work
• Experience auditing against recognized standards
• Experience of working under own initiative and in planning and prioritizing workloads
• Solid knowledge of medical devices
• Should have a flair for technical writing, essential for exhaustive report writing
If you're interested in applying, please submit your CV in English.
Kindly be informed you may be requested to provide DNV with additional documents for a background check.
You will be hired on local conditions.
Interviews will be held on an on-going basis.
-
Medical Device Assessors
hace 3 semanas
Barcelona, España DNV A tiempo completoDNV is a global leader and innovator in inspection, verification, testing and certification services. Founded in 1864, DNV is recognized as the global benchmark in quality and integrity. We encourage new ideas, we welcome people who challenge the way we do things, and we will be 100% committed to helping you reach your full potential. DNV Product Assurance...
-
Key Account Manager | Medical Device
hace 2 semanas
Barcelona, España Randstad España A tiempo completoNuestro cliente, especializado en ofrecer soluciones innovadoras que mejoran la vida de las personas con movilidad reducida mediante la estimulación sensorial y los beneficios de la terapia con agua.Tus funciones:- Captación de nuevos clientes a nivel nacional e internacional.- Fidelización de clientes (Organización de agenda de visitas)- Visitas...
-
Medical Device
hace 3 semanas
Barcelona, España DNV A tiempo completoDNV Product Assurance AS is one of the leading Notified Bodies for medical devices. Unit is entitled to carry out tasks related to conformity assessment of medical devices with EU Medical Devices Regulation before such products are placed on the market. The role of Internal Clinician is to assess clinical data supporting safety and performance of devices ...
-
Area Business Manager Europe
hace 2 semanas
Barcelona, España Pmfarma A tiempo completoA medical device company is looking for a Business Area Manager with the aim of develop the presence the company products in Europe by implementing promotional sales and distribution activities (searching, identifying, and closing agreements) while pursuing objectives and following the guidelines defined by the company and the Marketing and Sales...
-
Associate Director, Patient Safety Device
hace 2 semanas
Barcelona, España AstraZeneca A tiempo completo**About AstraZeneca** AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we are pioneering new...
-
Business Developer
hace 1 semana
Barcelona, España Marlex Human Capital A tiempo completoDesde Marlex Healthcare estamos colaborando con una empresa distribuidora de medical devices, con impacto a nivel nacional e internacional, con más de 30 años de historia, especializada en productos de neumología y pediatría y con un ritmo de facturación en alza qué necesita incorporar a un/a Business Developer en la zona de Barcelona, Tarragona y...
-
Quality Assurance Consultant
hace 6 días
Barcelona, España Ambit A tiempo completoQuality Assurance Consultant (Software as Medical Devices) | 100% RemoteWe are looking for a "Quality Assurance Consultant (Software as Medical Devices)" to provide services to a multinational pharmaceutical company. Work closely with the software engineering team to establish a strong cross-functional relationship with the various teams involved.Manage...
-
Business Intelligence Analyst
hace 4 semanas
Barcelona, España Marlex A tiempo completoDesde Marlex Healthcare estamos colaborando con una empresa distribuidora de medical devices, con impacto a nível nacional e internacional, con más de 30 años de historia, especializada en productos de neumología y pediatría y con un ritmo de facturación en alza qué necesita incorporar a un/a** Business Intelligence Analyst** en sus oficinas de...
-
Marketing & Medical Education Trainee
hace 6 días
Barcelona, España Alcon A tiempo completo¿Estás estudiando un Máster o Posgrado en Marketing, Comunicación, Periodismo? ¿Estás en búsqueda de prácticas?¿Quieres unirte a una Multinacional líder del sector Medical Device? ¡Esta es tu oportunidad! Ofrecemos un proyecto de prácticas mediante un convenio de 12 meses de duración que te permitirá poner en práctica y desarrollarte como...
-
Medical Project Coordinator Intern
hace 4 semanas
Barcelona, España ESTABLISHMENT LABS A tiempo completoEstablishment Labs is changing the breast aesthetics and reconstruction industry by designing, developing, and manufacturing an innovative portfolio of advanced breast health and wellness products branded as Motiva®. As a Medical Project Coordinator, Intern, you will be supporting two Regional Medical Education Managers and the Medical Education...
-
MSL / Medical Affairs
hace 3 días
Barcelona, España Timup A tiempo completoOur client is a global biotechnological company specialized in dermatology and sports medicine with the headquarters in Barcelona, with distributors in more than 60 countries.We are looking for a Medical Affairs/ MSL profile that will report to the Medical Director.Main Responsabilities:Medical EducationAcquire the required medical and product knowledge in...
-
Associate Director, Digital
hace 2 semanas
Barcelona, España AstraZeneca A tiempo completo**Typical Accountabilities, what you will be doing**: - Provide and be responsible for the medical and scientific input to the device and/or digital program’s design and development - Contribute to developing clinical device and/or digital documents, such as hazard assesssments, in collaboration with the Device & Digital Safety Physicians. - Review,...
-
Human Resources Business Partner
hace 3 semanas
Barcelona, España Knewin A tiempo completoHuman Resources Business Partner (Dutch speaker) Pay Competitive Location Barcelona/Catalonia Employment type Full-Time Job Description Req#: 747 About Us: Establishment Labs is changing the medical device, breast health, aesthetics and reconstruction industry by designing, developing, and manufacturing an innovative portfolio of advanced medical...
-
Delegado/a de Ventas
hace 3 semanas
Barcelona, España Adecco A tiempo completoInternacional especializada en fabricación de productos y material para quirófanos, busca incorporar a su fuerza de Ventas a un/a Delegado/a de Ventas para los canales hospitalarios y quirófanos, además de visita a distribuidores, a nível nacional e internacional (50% / 50%). Contactarás con la cartera de clientes existente, además de desarrollar y...
-
Global Head of Medical Excellence and Operations
hace 3 semanas
Barcelona, España Galderma A tiempo completoDescription The individual in this role will be a member of the Global Medical AffairsLeadership Team (GMALT) and interact with all levels of leadersacross Medical Affairs, R&D and cross-functionally. This position will provide support to the Global Medical AffairsHeadwith day-to-day and ad hoc operational business needs and requirements. Key...
-
Territory Manager Lleida
hace 4 semanas
Barcelona, España Applied Medical Europe B.V. A tiempo completoOverview: **Job Description**: Do you have experience in the operating room, for example as a trained nurse, a sales representative, a product specialist, and would you like to join a progressive medical device manufacturer? We are looking for a Territory Manager that will enjoy engaging with hospital staff, understanding their needs, and building...
-
Product Manager-medical Devices
hace 4 semanas
Barcelona, España D&M asesores consultores A tiempo completo**Product Manager-Medical Devices (Barcelona-Tarragona)**: **Empresa especializada en el sector medical devices en plena fase de expansión** Buscamos un responsable de producto con amplia experiência en el sector sanitario (hospitalario, residencial), conocimiento de producto y conocimiento de fabricantes nacionales e internacionales de “_medical...
-
Product Manager-Medical Devices
hace 4 semanas
Barcelona, España D&M asesores consultores A tiempo completoBuscamos un responsable de producto con amplia experiencia en el sector sanitario (hospitalario, residencial), conocimiento de producto y conocimiento de fabricantes nacionales e internacionales de “medical device” . Se valorará experiencia en esterilización, mobiliario, laboratorio… Debe ser una persona apasionada por crear/identificar productos y...
-
Sales Rep Iberia Ortho
hace 4 semanas
Barcelona, España Page Personnel España A tiempo completoEl representante de ventas será responsable de alcanzar el presupuesto de ventas de una determinada zona geográfica así como de la consecución de los objetivos comerciales y de ventas, proporcionando previsiones, asegurando cubrir las necesidades de los clientes y determinar soluciones centradas en el cliente, además de seguir las directrices...
-
40747 - Mechanical design engineer
hace 23 horas
Barcelona, España Barcelona Activa A tiempo completoDescripció de l'oferta Main task Design the mechanics of the medical device, adapting the electronic circuits and components of BraiN20 device and redesign the performance and assembly Secondary tasks - Collaborate with hardware designers, testers, biomedical engineers, and firmware and hardware engineer to develop device through the complete...
