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Contract Consultant Regulatory Affairs (DE)
[11408]
regulatory affairs
Job title: Contract Consultant Regulatory Affairs Industry: Medizintechnik Skills: Regulatory affairs Start of project: ASAP Duration of the project : 3 Months Project volume: 255 Stunde(n) Location: Schweiz Tasks: ·Accompanying development projects from the feasibility phase to the timely approval of products in international markets ·Preparation of regulatory strategies for the approval of products in different markets ·Collaboration with the disciplines R&D, Product Management, Medical Affairs, Industrialization and Quality ·Preparation and maintenance of regulatory documents such as intended use, classification, list of applicable regulations and standards, essential principles ·Collaboration with regulatory partners at customers and suppliers, authorities and conformity assessment bodies ·Registration of products worldwide; recertifications of products ·Approval of products worldwide; recertification of products ·Assessment, documentation and communication of changes to authorities and conformity assessment bodies ·Representation of regulatory requirements in the company (MDR, US and global requirements) ·Supporting further development of regulatory processes in the quality management system Qualifications ·Successfully completed scientific or engineering studies (or comparable education) ·Profound experience and knowledge in Regulatory Affairs for medical devices (drug-delivery devices, active and connected medical devices would be an advantage) ·More than 3 years' experience in the approval of products in the US, Canada and EU (further markets desirable) ·Pleasure in goal-oriented writing and reviewing of documents ·Systematic, quality-oriented and well-documented working method ·Team player with strong analytical skills who is proactive and solution-oriented ·Dedication and excellent communication skills ·Fluency in German and English
Skills: Regulatory affairs
Tasks:
- Accompanying development projects from the feasibility phase to the timely approval of products in international markets
- Preparation of regulatory strategies for the approval of products in different markets
- Collaboration with the disciplines R&D, Product Management, Medical Affairs, Industrialization and Quality
- Preparation and maintenance of regulatory documents such as intended use, classification, list of applicable regulations and standards, essential principles
- Collaboration with regulatory partners at customers and suppliers, authorities and conformity assessment bodies
- Registration of products worldwide; recertifications of products
- Approval of products worldwide; recertification of products
- Assessment, documentation and communication of changes to authorities and conformity assessment bodies
- Representation of regulatory requirements in the company (MDR, US and global requirements)
- Supporting further development of regulatory processes in the quality management system
Qualifications
- Successfully completed scientific or engineering studies (or comparable education)
- Profound experience and knowledge in Regulatory Affairs for medical devices (drug-delivery devices, active and connected medical devices would be an advantage)
- More than 3 years' experience in the approval of products in the US, Canada and EU (further markets desirable)
- Pleasure in goal-oriented writing and reviewing of documents
- Systematic, quality-oriented and well-documented working method
- Team player with strong analytical skills who is proactive and solution-oriented
- Dedication and excellent communication skills
- Fluency in German and English
David Langnas