Regulatory Specialists x5

Berkshire  ‐ Onsite
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Description

The Regulatory Affairs Specialist is responsible for the implementation of international regulatory strategies, priorities agreed among EEMEA Marketing and country management;

Main Responsibilities;
  • Define RA submission plan based on marketing and sales expectations
  • Communicate to divisions RA submission plan, registration priorities, time frames and regulatory requirements
  • Place request in the system to obtain product registration dossiers from Divisions, tailor them to meet country registration requirements
  • Pull out documents from documentation system
  • Support Local RA/QA groups in EEMEA for local product submission and getting support from divisions
  • Create, evaluate or update RA related policies and procedures to ensure regulatory compliance maintenance
  • Review and evaluate impact of product changes on registrations or product supply
  • Assist divisions in determining appropriate product testing to support International registrations, for products in R&D phase
  • Review and provide input on regulatory aspects related to distribution agreements


Necessary Experience;
  • At least 1-2 years experience in a international organizational business environment.
  • Must have experience of international Medical Device Registrations
  • Prior experience of product registration of Medical device in Europe and EEMEA .
  • Any experience in a MD area (also operational environment, good understanding of MD Business and processes).
  • Good understanding European and US FDA regulations and international standards applicable to medical devices industry.


If you believe you have the correct experience then please send me your CV and I will be in touch shortly
Start date
05/2015
From
Real Staffing
Published at
09.02.2015
Project ID:
847861
Contract type
Permanent
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