Regulatory Affairs Specialist EMEA

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Regulatory Affairs Specialist EMEA

Posted date | 10/03/2017 Closing date | 30/06/2017
Full Time Management
Pharma

Regulatory Affairs Specialist EMEA

A job vacancy for a Regulatory Affairs Specialist EMEA has arisen within the pharmaceutical industry. Your responsibilities will include:

  • Serve as a Regulatory Expert on cross-functional teams ensuring quality dossier
  • Collaborate with global regulatory counterparts to develop global, regional and country regulatory strategy
  • Identify key issues in complex situations while solving these issues with minimal assistance
  • Provide guidance to project teams in the area of design and analysis while coaching them on trade-off decisions
  • Conversant with respect to safety and performance profile of their products
  • Educate internal stakeholders on implications of regulations and also develop procedures in regulatory compliance matters
  • Plan formal meetings with regulatory agencies and negotiate project review teams ensuring positive outcomes
  • Facilitate the identification of risk elements for specific projects

Education & Experience

The vacancy requires a:

  • Possess a degree in Engineering or Life Science
  • Minimum 3 years of regulatory experience within a healthcare environment

Skills

  • Good knowledge of CE marking of medical devices
  • Ability to interpret European regulations and guidelines
  • Excellent organizational of project management skills
  • Open to innovation and risk taking
  • Strong written and spoken English

Our client, a multinational company operating in Malta with increased activity in its manufacturing and trading operations.

Job Reference Code : MT 1461/17p

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