Regulatory Affairs Specialist

2 months ago

Renfrew County, Canada Terumo Aortic Full time

Terumo Aortic is seeking a highly skilled Regulatory Affairs Associate to join our team during an exciting time of growth and expansion for the business. This is a fantastic opportunity for someone to join our Regulatory Affairs team in a rewarding role with a company that offers career development amongst a host of excellent benefits.

Key Responsibilities:

  • Support regulatory projects as required, ensuring compliance with relevant regulations and guidelines.
  • Support writing technical/submission documents for Custom devices, CE devices, and international registrations as required, utilizing strong technical writing skills.
  • Support CAPAs and SATs from initiation to closure as required, demonstrating attention to detail and analytical skills.
  • Review and maintain product approval certification database as required, ensuring accuracy and up-to-date information.
  • Requirements:
    • Experience within the medical device industry, with a strong understanding of regulatory requirements.
    • Strong analytical and problem-solving skills, with the ability to work independently and as part of a team.
    • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
    • Strong technical writing skills, with the ability to produce high-quality documents.

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