Clinical Regulatory Affairs Manager

vor 2 Wochen

Zurich, Schweiz Hays Vollzeit

**My duties**
- Directing and overseeing short-team and long-term planning of clinical data acquisition for regulatory submission initiatives
- Leading pre-market clinical investigations and post-market clinical follow-up of the clients’ medical devices, with the goal to reach earliest possible approval of regulatory submissions
- Designing clinical data collection strategies with internal clinical experts and external clinical and research partners, analyze collected PMCF data and oversee the execution of clinical studies
- Planning and conduction clinical evaluations of medical devices in accordance with MDR and FDA
- Negotiating with outside agencies to resolve key regulatory issues pertaining to the clinical evidence and/or clinical claims of medical devices
- Preparing responses to inquiries from regulatory authorities on the clinical evidence and/or claims of
- Review, evaluate, and compile clinical files and reports for regulatory submissions of medical devices
- Provide guidance on communication of claims and indications of medical devices to the marketing teams

**My qualifications**
- Advanced Degree in physiotherapy, occupational therapy, medicine, rehabilitation or human movement sciences or any other discipline with relevance to neurorehabilitation
- Professional working experience in clinical practice, clinical affairs, medical affairs and/or rehabilitation research
- Experience in conducting clinical evaluations for medical devices and providing clinical regulatory guidance throughout the product development lifecycle, including clinical study development and implementation, preferably for medical devices utilized in neurorehabilitation
- Proven ability to negotiate with outside agencies to resolve key regulatory issues pertaining to the clinical evidence and/or clinical claims of medical devices
- Strong clinical knowledge in neurorehabilitation.
- Strong knowledge of MDR, FDA, and Good Clinical Practice
- Preferred: Certification in Regulatory Affairs or other certification relevant to medical product development and/or audit
- Experience in medical writing
- Excellent communication skills
- Capable of interpersonal contacts and foster effective dynamics in interdisciplinary teams
- Business-Fluent in English and German

**My benefits**
- Exciting taks in a dynamic environment
- Excellent development opportunities in a growing medical technology company

**About Hays**
- With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages - completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.**My contact at Hays**

**My contact person**
Laura Feig

**Reference number**
629164/1

**Contact**
Phone:
+41-61-2250 - 522

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