Regulatory Compliance Manager - Medical Device French & English Fluent

10.10.2019 | Employee | 100%



For our pharmaceutical partner based in "Canton de Vaud', we are looking for a

Regulatory Compliance Manager - Medical Device
French & English Fluent - Permanent contract - %...

Regulatory Compliance Manager - Medical Device French & English Fluent



For our pharmaceutical partner based in "Canton de Vaud', we are looking for a

Regulatory Compliance Manager - Medical Device
French & English Fluent - Permanent contract - 100 %

Your responsibilities:

  • Implement and maintain system processes and SOPs for RC related activities
  • Maintain up-to-date knowledge of worldwide standards and regulatory submission procedures, analyses new and revised laws, guidance and standards (registration requirement database management)
  • Coordinate with R&D and RC associates for the overall management and sustainment of all product Technical Files (TFs) and/or Summary Technical Documentation (STED) for the Segment
  • Establish and maintain systems to ensure that EU Representatives and have the access to all relevant TFs for Notified Body audits
  • Ensure compliance with product-related external standards, including all applicable country-specific requirements
  • Cooperate with Marketing and Labelling Review teams and leadership to ensure that product labeling meets regulatory requirements for all markets, including corporate Website; ensure on-going management of country database systems for UDI (unique device identification)
  • Ensure effective classification, conformity assessment procedure and CE marking for MAI medical devices
  • Prepare documents for regulatory submissions in the US, including 510(k)'s. Submit applicable information to Corporate for site registration and device listings, and Canadian registrations
  • Ensure effective classification, conformity assessment procedure and CE marking for MAI medical devices
  • Ensure product registrations in all relevant markets worldwide
Your profile:
  • Bachelor's degree or equivalent in science or engineering
  • 3+ years in a manager in medical devices product registration role
  • Solid knowledge of national and international directives and regulations for medical devices and medicinal products
  •  Excellent interpersonal skills with a strong capacity to convince others
  •  Experience working in a matrix organization
  • Excellent communication skills in French (B2 min.) and English (C2); ability to adapt communication style as needed
  • Proactive, solution-oriented attitude
  • Flexibility and ability to lead change
 

10.10.2019
Employee, 100%

Contact

Kelly Scientific Genève
Amina Oumeziane
Rue du Rhône 114
1204 Genève
Fax: +41227371213
Kelly Scientific Resources
rue du Rhône 114
Geneve

Industry

Human resources / Personnel services
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