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Senior RA Manager Asia-Pacific Medtech Biologics

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Medical devices and biomaterials for medical and pharmaceutical applications are developed, manufactured and sold internationally by our customer, located in greater Zurich area. Ten national…

Senior RA Manager Asia-Pacific Medtech Biologics

Medical devices and biomaterials for medical and pharmaceutical applications are developed, manufactured and sold internationally by our customer, located in greater Zurich area. Ten national companies and over 50 distribution partners supply a global market with exclusive, high-quality products. The company currently employs more than 600 people worldwide.
The international Regulatory Affairs department at the headquarters looks after the entire product range of biomaterials and medical products and accompanies many new developments. The classic product lines have worldwide approvals in the core markets of the EU and the USA, as well as in China, various Asian countries and Latin American countries. The Regulatory Affairs department processes new developments and product improvements continuously, renews existing approvals and submits new approvals or extensions to indications.
We’re looking for an experienced RA specialist for the growing Regulatory Affairs department. In this role you will elaborate international regulatory strategies and prepare technical documentation and registration dossiers with focus on Asian countries (e.g. Japan, China). You lead complex registration projects, in collaboration with internal departments and are the SME for a Regulatory evaluation of product changes and interpretation of regulation changes with internal trainings. You will also support audits conducted by notified bodies and regulatory authorities. You will be in direct communication with partners, authorities, and agencies globally within the company network.

Your profile:

  • University degree in natural sciences: University of applied sciences/university/PhD
  • >5 years of professional experience in RA Medical Devices, MDD, MDR
  • Experience in preparing dossiers, responding to inquiries from authorities
  • working experience with Asian markets
  • good understanding of intercultural collaborations


Your have an excellent knowledge of English; some understanding of German. You are an open person who exchanges ideas with other departments and acts as an advisor to the team. You carefully manage projects and reliably monitor the deadlines in the approval and recertification/submission process. You work precisely, efficiently and independently.

Address

gloor & lang ag life science careers
Frau Irmtraud Lang
Senior Consultant
Bahnhofstrasse 31
5400 Baden
+41 61 206 61 81

Email

Website http://www.gloorlang.com

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