A leading medical device company is seeking to hire an RA Specialist to their office based in Switzerland. This organisation has been developing trusted and innovative cardiovascular solutions for over 50 years, driven by a dedication to progress, innovation, and exceptional quality. This position offers the exciting opportunity to work with a historic and prolific company and marry its uncompromising quality standard with real expertise in the regulatory field.
- Overseeing regulatory aspects during the development of new VI products (regulatory strategy, applicable standards and guidelines).
- Registering VI devices in the CE and other highly regulated countries.
- Maintaining regulatory documentation up to date for worldwide regulatory purposes.
- Implementing regulatory aspects of labeling, taking account of worldwide regulatory labeling requirements.
- Establishing and updating internal procedures to enable up to date and consistent output, as well as efficient workflow within the department and project team.
- Coordinating and submitting deficiency responses to relevant certification bodies and country authorities.
Skills and Requirements:
- University degree in natural science, pharmacy, pharmacology, medicine, or engineering.
- At least 2-3 years of experience with worldwide registrations of medical devices and/or combination products in relevant countries, particularly in the CE region and USA.
- Excellent knowledge of the applicable medical device regulations in the aforementioned countries including current developments (MDR).
- Fluency in English language mandatory, German and any other language an advantage.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Joe Beddows at +44 203 854 262 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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