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Regulatory Affairs Specialist

2 months ago

Mississauga, Ontario, Canada Myant Full time
About Myant

Myant is a pioneering technology company that is revolutionizing the way we interact with technology. Our mission is to create a world where technology is seamlessly integrated into our daily lives, enhancing our well-being and connectivity. We are a multi-disciplinary team of innovators, engineers, and designers working together to push the boundaries of what is possible.

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will play a critical role in ensuring that our medical devices comply with international regulations and standards. You will be responsible for developing and implementing regulatory strategies, preparing and submitting regulatory documents, and collaborating with cross-functional teams to ensure compliance.

Key Responsibilities
  • Develop and implement regulatory strategies for new and existing products to ensure compliance with global regulations
  • Work closely with cross-functional teams to integrate regulatory requirements into product development and lifecycle management
  • Prepare and submit regulatory documents, including premarket notifications, premarket approval applications, technical files, and design dossiers, to regulatory authorities
  • Monitor and interpret regulatory requirements, guidance documents, and industry standards to ensure compliance
  • Communicate regulatory requirements to internal stakeholders and provide regulatory support and guidance throughout the product development process
Requirements
  • Bachelor's degree in Engineering, Life Sciences, or a related field; advanced degree preferred
  • Minimum of 5-7 years of experience in regulatory affairs within the medical device industry
  • In-depth knowledge of FDA, Health Canada, EU MDR, and other relevant medical device regulations
  • Strong understanding of ISO 13485 and ISO 14971 standards
  • Excellent organizational, communication, and project management skills
What We Offer
  • Employee stock options
  • Paid Sick Days and Floating Days
  • Group Health Insurance Plan
  • RRSP matching Plan
  • Corporate Events