Clinical Evaluation Manager job in Zürich, Switzerland

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Clinical Evaluation

Location: Switzerland

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting a Clinical Evaluation Manager for a medical technology devices organisation on a permanent basis. As a Clinical Evaluation Manager, you will be handling the development of clinical strategies and submission documentation for first in ma, regulatory submission and post market trials for their class III devices.

Responsibilities:

Advance, revise and review clinical strategies/ clinical evaluation plans, clinical evaluation reports, PMCF plans and reports, summaries of safety and clinical performance and clinical investigator brochures. The documents are presented to regulatory authorities and informed bodies.
Manage the quality, accuracy, and timely production of reports/ plans.
Run literature searches/reviews as necessary to obtain and maintain up to date knowledge for the development of documents and for providing subject matter expertise to other departments.
Support risk management activities like development and maintenance of product risk analyses and benefit-risk assessments.
Act as a core team member for product development projects.
Interfaces with risk management, R&D, regulatory affairs, study managers, biostatisticians and marketing.

Skills & Requirements:

Required to have a MD or PhD ideally in the field of Cardiovascular Science.
At least 2-5 years of experience in medical writing, preferably in a similar industry comprising of clinical study reports and protocols, as well as a demonstrated track record of publications in peer reviewed journals as the main author.
Good understanding of statistics, together with the ability to interpret complex clinical data.
Be team oriented, accurate and self-dependent personality with an analytical working style.
Knowledge of MEDDEV 2.7/1 rev. 4 and MDR.
Familiarity with ISO 14971 and FMEAs, as well as knowledge in Risk Management is a plus.
Exceptional presentation and moderation skills, including technical editing and QC skills.
Excellent command of spoken and written English and German.

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 call Josh Volpe on +44 203 800 1292.

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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