Beschreibung
- As a modern company, our client manages to constantly develop further and break new ground.
Senior Regulatory Affairs Specialist - JNJKJP (m/f/d)
Reference: -en
Start: asap
Duration: 7 MM++
Main tasks:
- Support preparation of technical documentation or design dossier documentation for submission to and review by Notified Bodies, as required (both MDD and MDR) as assigned
- Provide regulatory support for Life Cycle Management projects as assigned
- Manage data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned
- Perform Regulatory reviews for Labelling and Promotional Material of CE marked devices
- Perform Regulatory Change assessments as assigned
- Support compliance execution work in collaboration with local Regulatory Team
Main qualifications
- Profound and in-depth experience in the Medical Device industry and Regulatory Affairs
- Understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) )
- Understanding of requirements of current Council Directive 93/42/EEC
- Previous experience within Regulatory Affairs at DePuy Synthes preferred
- Experience with creation and maintenance of Technical Documentation in PLM Systems preferred
- Experience in IT system documentation and database management preferred
- Experience with MS Office (Excel, Access) for data analyses and comparisons
- Ability to comprehend principles of engineering, physiology and medical device use
- Strong analytical skills and proficiency in English (written and spoken); German skills would be an asset
Main advantages:
- A very renowned company
- A highly motivated team and an open way of communication
- You will work in an international environment
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.
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