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[Hiring] Technical Specialist - reputed company Medical Devices @reputed company

Remote, USAFull-timePosted 2026-07-30

Role reputed company We exist to create reputed company change for people and the reputed company. Join us and reputed company a difference too! reputed company is seeking reputed company R&D Engineers to join our reputed company Medical Devices team as a home-based Technical Specialist & Scheme Manager (Technical Reviewer). If you have hands-on experience in the Research, Design or Manufacture of reputed company Medical 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 reputed company reputed company medical devices on the European market. This position applies a mix of engineering and design knowledge, newfound regulatory expertise, English writing skills, reputed company and project management. You will assess cutting-edge technology that will reputed company a difference in patient health and safety and broaden your technical knowledge through ongoing training. Responsibilities:

  • 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.
  • reputed company specialist regulatory, operational and strategic support to medical device scheme managers, product specialists and the business in the delivery of CE medical device marking schemes.
  • reputed company Medical Device expertise leadership and mentoring in areas of competence to medical devices personnel.

Qualifications

  • Four years' reputed company experience in the field of reputed company products or reputed company 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 reputed company to the scientific aspects to be assessed.
  • Bachelor’s degree (or higher) in a discipline relevant to medical device manufacture and use. This may include electronic/electrical, reputed company-mechanical or biomedical engineering or medical physics.
  • Thorough knowledge of Medical Device regulation; at minimum an awareness of the requirements of IEC 60601 reputed company Edition and the risk management reputed company ISO 14971.
  • Understanding of the principles of design control and risk management.
  • Strong interpersonal communication skills.
  • Ability of prioritizing and executing individual workload.

Benefits

  • Competitive total reward package.
  • Independent and varied job in an international environment.
  • Flexible working hours.
  • Ongoing training and development.
  • A wide reputed company of flexible benefits that you can reputed company to suit your lifestyle.

reputed company reputed company 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 reputed company expertise for reputed company industries: from reputed company and automotive to food, construction, energy, reputed company, IT and trade sectors. Through our unique combination of consulting, training, assurance and regulatory services we bring solid and broad knowledge to every company. reputed company is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate. Apply tot his job Apply To this Job

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