Regulatory Affairs Associate

Regulatory Affairs Associate

Responsible to: Regulatory Affairs Manager
Purpose of Job (Summary)

To support the Regulatory team to ensure compliance with regulations within Europe and globally, to register new and existing products with regulatory authorities to allow for growth of the business and to support with key regulatory projects within the business.

 

Key Responsibilities

  • Support with maintaining technical files and design dossiers in accordance with regulatory requirements
  • Preparation and tracking of assigned regulatory submissions for global product registrations
  • Assist with ensuring compliance of IFUs, packaging and labelling materials and marketing literature
  • Support the Regulatory Affairs Manager with input into key regulatory projects, new product development projects and change projects
  • Assist with the process for implementation of new/changed standards and regulations.
  • Maintenance of specific compliance training programs
  • To undertake any other reasonable duties

Qualifications / Experience

  • Relevant science or engineering degree.
  • A passion and an understanding of what regulatory affairs is
  • Excellent communication skills (both written and oral) and an eye for detail
  • Good organizational, IT and administrative skills
  • Ability to meet strict deadlines

Responsible to: Regulatory Affairs Manager
Purpose of Job (Summary)

To support the Regulatory team to ensure compliance with regulations within Europe and globally, to register new and existing products with regulatory authorities to allow for growth of the business and to support with key regulatory projects within the business.

 

Key Responsibilities

  • Support with maintaining technical files and design dossiers in accordance with regulatory requirements
  • Preparation and tracking of assigned regulatory submissions for global product registrations
  • Assist with ensuring compliance of IFUs, packaging and labelling materials and marketing literature
  • Support the Regulatory Affairs Manager with input into key regulatory projects, new product development projects and change projects
  • Assist with the process for implementation of new/changed standards and regulations.
  • Maintenance of specific compliance training programs
  • To undertake any other reasonable duties

Qualifications / Experience

  • Relevant science or engineering degree.
  • A passion and an understanding of what regulatory affairs is
  • Excellent communication skills (both written and oral) and an eye for detail
  • Good organizational, IT and administrative skills
  • Ability to meet strict deadlines

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