Descripción de la vacante
BSI Group
£58,500 - £78,000 a year
Spain
Technical Specialist - Active Medical Devices en Spain - Homebased, Spain, España is listed on Jobeax. Browse 80,000+ vacancies available.
We exist to create positive change for people and the planet. Join us and make a difference too!
Job title: Technical Specialist & Scheme Manager - Active Devices
Location: Global Homebased
BSI is seeking experienced medical device professionals to join our Active Medical Devices team as a home-based Technical Specialist and Certification Scheme Manager (Final Reviewer). If you have hands-on experience in the research, design, manufacture or testing of active devices we'd love to hear from you.
As a Technical Reviewer, you will work with medical device manufacturers throughout their certification life cycle to place active medical devices on the European market. This position applies a mix of engineering and design knowledge, newfound regulatory expertise, English writing skills, client and project management. You will assess cutting edge technology that will make a difference in patient health and safety and broaden your technical knowledge through ongoing training.
Review and evaluate medical device technical and clinical documentation in your areas of competence to assess compliance with MDD 93/42/EEC, MDR 2017/745 and UK MDR 2012 schemes.
Manage certification activities for a portfolio of medical device manufacturers, including determination of auditing requirements and making recommendations for the issue and maintenance of CE certifications.
Provide specialist regulatory, operational and strategic support to medical device scheme managers, products specialists and the business in the delivery of CE medical device marking schemes.
Provide Medical Device expertise leadership and mentoring in areas of competence to medical devices personnel.
Four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed.
Bachelor's or higher degree in a discipline relevant to the medical device industry. This may include electronic/electrical, electro-mechanical or biomedical engineering or medical physics.
Familiarity with the Medical Devices Regulation (EU)2017/745 and/ or Medical Devices Directive 96/42/EEC is an advantage.
At minimum, an awareness of the requirements of IEC 60601 family of standards and the risk management standard ISO 14971.
Understanding of the principles of design control and risk management.
Strong interpersonal communication skills.
Ability of prioritizing and executing individual workload.
Candidates with professional experience gained in accredited testing laboratories and a broad exposure to a range of active medical devices have been successful in the role.
Interested? To apply for this role please submit your application today and take the next step in your career as a Technical Reviewer with BSI.
BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development. The salary for this position for the UK can range from £58,500- £78,000 annually; actual compensation is based on various factors, including but not limited to, the candidate's competencies, level of experience, education, location, divisional budget and internal peer compensation comparisons. If you are based in the EU, your recruiter can inform you of the local salary banding which differs per country based on various factors.
BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.
Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.
Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.
Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society's critical issues - from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.
BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.
We are proud to be the business improvement company for other organisations to become more sustainable and resilient and finally to inspire trust in their products, systems, services, and the world we live in.
Headquartered in London, BSI is the world's first national standards organization with more than 100 years of experience. We are a global partner for 86,000 companies and organizations in over 193 countries, offering development, auditing, certification, and training services, including innovative software solutions and cyber security expertise for all industries: from aerospace and automotive to food, construction, energy, healthcare, IT and trade sectors. Incorporated by Royal Charter, we're truly impartial, and home to the ultimate mark of trust, the Kitemark.
Through our unique combination of consulting, training, assurance and regulatory services we bring solid and broad knowledge to every company.
If you want to contribute to this inspiring challenge, bring your open and enthusiastic mindset to our dynamic team,
BSI is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate. Our goal is to create a sense of belonging for all employees by providing opportunities to develop, grow, and engage with our global organization all while having fun doing great work. BSI is a community where everyone can thrive.
If you require any reasonable accommodations to be made on account of a disability or impairment throughout out our recruiting process, please inform your Talent Acquisition Partner.
Vacantes similares
IQVIA Argentina
IQVIA in Madrid is seeking a Product Data Officer (Medical Devices) for a hybrid, full-time role on a temporary contract. You will manage product data quality, standardization, and governance to support medical device workflows and regulatory compliance. The position offers exposure to health data services in a global organization, ...
Spain, Madrid
... temporary position offers an exciting opportunity to join a multicultural, dynamic, and collaborative team while developing expertise in the rapidly growing Medical Devices sector. As a member of the P roduct Reference Team, you will contribute to the creation, maintenance, and enhancement of the Global Medical Devices ...
Spain, Madrid
Rob Surgical
... Engineering or another relevant scientific discipline. At least 6 years of experience in Regulatory Affairs within the Medical Device industry. Experience preparing Technical Documentation for medical devices. Knowledge of European Medical Device Regulation (MDR 2017/745). Strong understanding of medical device regulations, standards ...
Spain, Barcelona
Permanent contract
... - Contributes to team effort by accomplishing related results as needed. - Close contact with the R+D team to find and fix the sources of errors. - Performs active testing of medical devices - Provide replacements to customers according to the warranty process. - Generates reports on the different devices of the company ...
Spain
... We are looking for a motivated junior professional who wants to develop their career in the MedTech and IVD sector. As a Clinical Research and Regulatory Specialist , you will support clinical research activities, scientific and medical writing, and the creation of documentation essential to product validation and regulatory ...
Spain, Pamplona
... We are looking for a motivated junior professional who wants to develop their career in the MedTech and IVD sector. As a Clinical Research and Regulatory Specialist , you will support clinical research activities, scientific and medical writing, and the creation of documentation essential to product validation and regulatory ...
Spain, Coruña
... We are looking for a motivated junior professional who wants to develop their career in the MedTech and IVD sector. As a Clinical Research and Regulatory Specialist , you will support clinical research activities, scientific and medical writing, and the creation of documentation essential to product validation and regulatory ...
Spain, Málaga
... We are looking for a motivated junior professional who wants to develop their career in the MedTech and IVD sector. As a Clinical Research and Regulatory Specialist , you will support clinical research activities, scientific and medical writing, and the creation of documentation essential to product validation and regulatory ...
Spain, Alacante
Localizationacademy in Spain seeks qualified Polish linguists to support ongoing Medical Devices and Regulatory language projects for multiple clients. You will work across translations, edits, and QA tasks. Requirements include native or advanced Polish, high English... Idioma inglés Polaco
Spain, Altea
£63,400 - £74,500 a year
About the role Job Title- Technical Specialist- IVD (In Vitro Diagnostic) BSI is seeking R&D Scientists and Production Scientists to join our IVD Devices Team as a Technical Specialist and Scheme Manager for CE Marking clients. Specifically we are seeking people with knowledge of the design and manufacture of IVD cancer ...
Spain
Full-time hours
About the role We are seeking a highly skilled SAP Technical & Service Delivery Specialist with expertise in S/4HANA to join our team at Airbus Defence and Space SAU. This role is unique in its dual focus: providing deep SAP Basis expertise while acting as service delivery manager (SAP Hosting) coordinating our service ...
Spain
... We are looking for a motivated junior professional who wants to develop their career in the MedTech and IVD sector. As a Clinical Research and Regulatory Specialist , you will support clinical research activities, scientific and medical writing, and the creation of documentation essential to product validation and regulatory ...
Spain, Castro
... We are looking for a motivated junior professional who wants to develop their career in the MedTech and IVD sector. As a Clinical Research and Regulatory Specialist , you will support clinical research activities, scientific and medical writing, and the creation of documentation essential to product validation and regulatory ...
Spain, Vitoria
... changes in medical science and technology. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As a Field Technical Engineer within our Electrophysiology ...
Spain, Madrid
Element Solutions Inc
44723 €/año
... interactions with customers, colleagues and other stakeholders, to drive financial performance and create a rewarding work environment. Who are we looking for? As a Technical Specialist, you will bring deep technical expertise and strong problem-solving capabilities to support the implementation and optimization of advanced surface-finishing ...
Spain, Castelló de la Plana
€35,000 - €44,000 a year
... in the automotive sector, a global leader in the development and marketing of innovative, electric, and hybrid vehicles, is looking to hire an After-sales Technical Support Specialist (Automotive) for its offices located in Alcobendas (Madrid). What you'll do - Provide first and second level technical support to the dealer ...
Spain
€22,000 - €28,000 a year
About the role Telefónica is seeking a dedicated Technical Support Specialist to join our growing team in Madrid. This is a Full-time, on-site position where you will be at the forefront of delivering exceptional customer service. You will handle technical inquiries from our diverse customer base, troubleshoot connectivity ...
Spain, Madrid
Permanent contract
... an industry leader - we would love to hear from you! What you'll do: As a Technical Support Specialist, your key area of responsibility will be diagnosing technical issues and providing the necessary support to resolve problems for both hardware and software-related issues within Geotab products (e.g. GO devices), the ...
Spain
£50,000 - £75,000 a year
... acquisition channel. Your role is to ensure our content is as discoverable as possible across both traditional search engines and AI-powered search. - Be the technical SEO lead for a team of seven writers. - Conduct technical SEO audits (site architecture, crawling, indexation, Core Web Vitals, schema, internal linking, etc.). ...
Spain