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Regulatory Affairs Manager, Device/ Diagnostics (896897-JK)

CTC Resourcing Solutions

 
Basel Area
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Our client, a dynamic medical device company based in Switzerland, specialized in implants and surgical, is looking for a Regulatory Affairs professional on a permanent basis.

The ideal candidate should be a highly motivated individual with at least 3+ years of experience regulatory affairs in the fields of medical technology or pharmaceuticals.

Regulatory Affairs Manager, Device/ Diagnostics (896897-JK)

Our client, a dynamic medical device company based in Switzerland, specialized in implants and surgical, is looking for a Regulatory Affairs professional on a permanent basis.

The ideal candidate should be a highly motivated individual with at least 3+ years of experience regulatory affairs in the fields of medical technology or pharmaceuticals.

 Main Responsibilities:

  • Ensure that regulatory guidelines for the approval of devices are met during the product development process;
  • Responsible for the regulatory content of product-related details and its release;
  • Conducting risk assessment, conformity assessment and initiating designing of the declaration of conformity;
  • Supporting and advising commercial team throughout the entire lifecycle of the products and ensuring that the technical documentation of the products complies with the regulatory requirements;
  • Responsible for Market release of medical devices;
  • Coordinate international registration submissions;
  • Involved in preparation and execution of audits;
  • Support and consulting R&D and Product management team in the interpretation of regulatory requirements;
  • Communication of new regulatory approval requirements to R&D as well as brand management and support in the implementation.

 Qualifications and Experience:

  • BSc/MSc/ studies in engineering/studies in the field of medicine;
  • 3+ years of experience in Medical Devices or Diagnostics or Pharma/Biotech;
  • Experience in Regulatory lifecycle management of medical devices;
  • Additional experience in Quality Management or Product Development is a big advantage;
  • Knowledge of MDD 93/42/EEC (product classification, definition of applicable standards, conformity assessment procedures) and other relevant regulations MDR 2017/745;
  • Proficiency in IT Tools: MS Office Software (Word, Outlook, Excel, PowerPoint); ERP/SAP;
  • Excellent written and oral communication skills in English & German desirable;
  • Accuracy and attention to details;
  • Ability to multitask in interdisciplinary environment;
  • Relevant working/residency permit or Swiss/EU-Citizenship required.

Address

CTC Clinical Trial Consulting AG
Mr CTC Resourcing Solutions
Münchensteinerstrasse 41
4052 Basel
+41 61 695 88 66

Website http://www.ctcresourcing.com

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