Description
Regulatory Affairs Group Leader - Medical (m/f)
Reference: -en
Start: 10/18
Duration: 12 MM++
Main tasks:
- Create a network of support to provide technical expertise during preparation of submission and in case of requests from authorities during the registration process
- Identify and create the appropriate documentation to meet registration needs for product submissions
- Analyse, interpret and communicate international regulatory requirements
- Provide support to internal and external clients by answering requests for regulatory information and advice in a timely manner
- Offer support to improvement projects
- Provide support to quality audits
- Promote quality and regulatory compliance by presenting regulatory affairs activities to EMS stakeholders
- Effective management of ERP, documentation, Excel and Key Performance Indicators (KPIs)
- Responsible for the selection and support of team members, motivation by training, performance evaluation, reporting and conflict management
Main qualifications
- Bachelor's degree in Regulatory Affairs or equivalent
- Profound experience in regulatory affairs
- Experience in the medical device industry
- Knowledge of European and international medical device directives, regulations and standards
- Knowledge of technical writing skills and budget management
- Experience working with international businesses or cultures
- Team management experience and training
- Good oral and written communication skills
- Fluent in English and French
Main advantages:
- Interesting tasks in a multinational environment
- Good infrastructure
- Support throughout the entire application process
About us:
With over 15 years of experience in the pharmaceutical industry, 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 professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Veronika Walz
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