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  • Location

    ANTWERP, Belgium

  • Job title:

    Regulatory Affairs Specialist

  • Sector:

  • Job type:

    Permanent

  • Job ref:

    44342

  • Startdate:

    2020-06-17

The Company

Our partner is an innovative company that markets skin care products. They are currently an established name in Europe and are growing very fast in the US.
 

Role Description

We are looking for a fulltime Regulatory Affairs Specialist.
 

Requirements

Your qualifications & experience

  • You support the Regulatory Affairs’ department in preparing product technical dossiers and other regulatory documents for registration submissions in and outside EU
  • You support the Regulatory Affairs’ department in keeping product technical dossiers and other regulatory documents up to date during the lifecycle of Flen’s products
  • You participate in the implementation of the new Medical Device Regulation within Flen
  • You ensure the regulatory compliance of communication activities and materials (brochure, presentation, packaging material etc.) regarding Flen’s products, in close collaboration with marketing and sales
  • You keep abreast of international legislation, guidelines and customer practices by keeping in contact with official institutions
  • You identify evolving regulatory trends including international trends that are relevant and ensure that appropriate action is initiated
  • You work in close collaboration with and report to the Manager Regulatory Affairs

Your profile:

  • Master’s degree in Pharmaceutical Science or Master in Science or equivalent based on relevant experience.
  • At least two years of professional experience in Regulatory Affairs for medical devices
  • Experience in international regulatory affairs is required; knowledge of regulatory affairs related to FDA and other non-EU regulations also
  • Project management knowledge is an asset
  • Familiar with MS Office and database applications
  • English is mandatory; Strong communication skills both written and verbal
  • Excellent planning and organisational skills
  • Quality minded
  • Strong interpersonal skills
  • Problem solving ability
  • Strong analytical ability


Offer

  • Excellent working conditions
  • An innovative and inspiring work environment
  • Independent project work & responsibilities within a professional team
  • Career prospects
  • Learning and development opportunities
  • Competitive remuneration according to experience
  • Become a member of the Management Team

Contact