RA Associate

 — Geneve
09.10. | Employee | 100%

Our client is currently looking for a RA Associate to support the Head of the department.

RA Associate

  • This position will be focused on the registration of Class III medical devices, in particular on US and other countries:
1- Preparation of registration dossiers
2- Manage the follow-up of the registration procedures, prepare and liaise with Competent Authorities
3- Assist the team in the Regulatory evaluation of US changes (Change control)
4- Manage the maintenance of registration dossiers (modifications and renewals)
  • Define the regulatory strategy in the framework of the development of new products in close collaboration with internal departments
  • Prepare and support audits
  • Be the regulatory affairs representative in the varied project teams
  • Key contact and support for distributors
  • Follow-up the regulatory monitoring for medical devices

A minimum of a B.Sc. in a Life sciences subject (Pharmacy, Chemistry, Biology or related discipline).

Post-approval experience with at least one of the main Regulatory authorities is required (FDA, Health Canada, EU).

Minimum experience required 2 years.

An understanding of manufacturing process, in process control, analytical process, stability studies would be beneficial

English and French fluent both oral and writtenEffective organisational/project management skills.

Demonstrable aptitude for IT packages such as Word, Excel, Access & PowerPoint.

Experience of database design/programming languages would be desirable

09.10.2020
Employee, 100%

Contact

Interiman SA


Interiman SA

.Actif en Suisse Romande

Industry

Human resources / Personnel services

Year of foundation

1998

Interiman SA

.Actif en Suisse Romande

Industry

Human resources / Personnel services

Year of foundation

1998
Salary

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