Regulatory Affairs Manager (m/w/d) - Medical Devices

Unternehmen : Joimax Gmbh

Auftragstyp : Vollzeit

Karlsruhe

Arbeitsbeschreibung - Regulatory Affairs Manager (m/w/d) - Medical Devices

Preparation and maintenance of the necessary documentation for the approval of medical devices (focus on endoscopy / spine) on the international markets
Monitoring international regulatory requirements and market-specific registration requirements
Implementation of regulatory requirements in coordination with internal process owners from R&D, product management and sales
Processing of amendment and renewal procedures and maintenance of existing registrations
Close communication with external bodies and authorities worldwide and continuous further development and improvement of processes

Successfully completed studies in the field of natural sciences, medicine, engineering or technology or equivalent qualifications
Relevant professional experience in the field of medical device regulation
Comprehensive knowledge of regulatory affairs with a focus on international product approvals
Experience of working in a quality management system and knowledge of European and international medical device regulations, directives, guidelines and standards
Very good knowledge of German and English

Become an Endoscopic.Spine.Expert. with the help of our own joimax ESPINEA® Academy. Great colleagues support you with your individual induction, encourage and challenge you to achieve common goals and sometimes swim against the tide
The right benefits count - whether it's fresh fruit and drinks, offers from the Corporate Benefits Programme for private shopping at home or the flexible, rechargeable prepaid credit card for everyday life
Turbulent times? We offer security with our pension schemes, group accident insurance and capital-forming benefits
Long-term and sustainable - this is how we plan with you, including an attractive salary, 30 days' annual leave (for a full-time position), a permanent employment contract and flexible working hours

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Regulatory Affairs Manager (m/w/d) - Medical Devices

Arbeitsbeschreibung - Regulatory Affairs Manager (m/w/d) - Medical Devices

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