Conformity Assessment of Medical Devices

At Monster Career we enjoy connecting smart professionals with new challenging projects! To do so, we’re cooperating an international certification body with headquarters in Prague, which operates in more than 50 countries in Europe, Asia, and Latin America.

Prague English

Active Medical Devices MDR Medical Medical Devices

About the company

Currently, they are focused on the extension of services in the healthcare and medical devices sector in order to offer to their clients conformity assessment services and CE certification of medical devices.

For this, we are supporting them in looking for experts in active medical devices to join their newly established team focused on conformity assessment of medical devices according to the MDR – the new and challenging European regulation.

Role description

•Assessments and reviews of design dossiers and other manufacturer’s documentation on the device’s performance and safety, determine whether
a device is in conformity with relevant standards and provides his/her expert opinion and recommendations to other team members.
•Key activities in this role also include communication and coordination of your activities with other team members, sharing experience and expertise with them, continuous learning as well as an opportunity to cooperate on the development of internal company procedures, based on your level of experience.
•Since this is a very versatile role, strong communication, project management, and analytical skills are also essential as well as responsibility and attention to detail.

•Minimum 4 years of total working experience in medical devices industry within a manufacturer, research and design institution, testing laboratory or certification authority in a role covering e.g. design and development (design engineer, project manager), manufacturing (technologist, production quality assurance), quality assurance and regulatory affairs, product testing, inspection or auditing and conformity assessment.

•Minimum 2 years of specific working experience (can be included within overall 4 years) in design and development OR manufacturing OR testing AND covering the following medical devices’ types in particular: active medical devices for physiotherapy, rehabilitation, and stimulation (e.g. diathermy, ultrasound therapy, magnetotherapy, electrotherapy, laser therapy, shockwave therapy, neuromuscular stimulators transcranial stimulators (ECT), lymphatic drainage devices) OR active medical devices for diagnosis (e.g. ECG devices, Holter monitors, spirometers, automated blood pressure monitors, oximeters – SpO2 monitors) OR active devices used in aesthetics (e.g. devices for liposuction, ultrasonic and high-frequency devices for adipose tissue reduction, IPL (intense pulsed light) devices, cosmetic lasers and UV-radiation devices for body shaping,
skin resurfacing, hair removal and tattoo removal).

•Minimum 2 years of specific working experience (can be included within overall 4 years) gained by working in a conformity assessment body (notified body) for active medical devices as an auditor OR technical expert/assessor in conformity assessment (CE marking) in the field of devices specified in the previous point.

Education – university or technical college diploma in area of engineering (electrical, mechanical, biomedical, IT), applied physics or similar field.

•Language proficiency: English B2/C1

•Home office, 5 weeks of holidays, laptop, mobile phone.
•The cooperation would be divided like this:
Phase 1: During 12 months you would be supporting the company part-time from home.
Phase 2: After one year you would be working full-time either from home or in Prague, (up to your decision!).


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