Clinical Evaluation Manager

Vor 7 Tagen

Zurich, Schweiz Proclinical Vollzeit

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.
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.

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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