Working at KitoZyme

Regulatory Affairs Specialist

Medical devices & Food supplements 

 

KitoZyme is looking to further strengthen its Regulatory Affairs team, a Regulatory Affairs Specialist able to handle the following responsibilities and tasks:

  • Manage multiple Regulatory Affairs projects and activities in line with KitoZyme’s product portfolio and regulatory requirements
  • Preparation, writing and revision of regulatory files for CE marking of medical device, notification of food supplements and approval of KitoZyme’s ingredients in different countries
  • Risk management
  • Data collection, analysis and synthesis to support product development and regulatory strategy
  • Interaction with to relevant national competent authorities, notified bodies,  and government agencies
  • Ensure timely communication of regulatory approvals and implementation dates
  • Scientific and technical files for safety/efficacy demonstration and claim substantiation
  • Provide intelligence regulatory strategies and input for developing and improvement of products
  • Keep up to date with EU/national and international legislation, guidelines, regulatory environment and customer practices
  • Ensuring that customer requests comply with the regulations requirement
  • Provide cross-functional colleagues and key stakeholders with regulatory advice and information.
  • Build expertise of specified products and share it with the Sales & Marketing Team
  • Specific activities related to Medical Devices:
  • Preclinical and clinical evaluation of medical devices
  • Post marking activities including proactive data collection, materiovigilance and Post Market Surveillance
  • Participate to the Innovation board and steering committees
  • Populate and maintain Regulatory Databases/ensure timely implementation and compliance
  • Ensure full compliance to legal requirements and to internal KitoZyme procedures
  • Participate to  inspections and audits and give appropriate follow-up

 

Profile

  • Master degree in Pharmacy
  • You have significant experience in a similar function of 10 years
  • Good knowledge of the European regulation: European Medical Device Regulations, regulation related to food supplement in Europe and in other countries, and how this impacts regulatory strategy and implementation; insight and understanding of stakeholder needs
  • Experienced with Risk Management for medical devices
  • Experienced with Technical File / Dossier documentation
  • Proven ability of interpreting legislation and impact to meet commercial needs
  • Excellent attention to detail and strong problem solving skills
  • Teamwork oriented, self-organized , able to work with within a cross functional team
  • Analytical thinking; quality and compliance oriented
  • Excellent written and oral communication and interpersonal skills
  • Fluent in French and English

 

Offer

We provide you a working environment in an innovative company where personal development, growth, team spirit and initiatives are encouraged.

We offer you a long term contract and an attractive salary based on your experience.

 

Interested ? Apply now for this function 

 

 

 

 

 

 

 

 

There is no open position at this time