Regulatory Affairs Expert

2 weeks ago

Calgary, Alberta, Canada Fluid Biomed Inc. Full time
About the Role

Fluid Biomed Inc. is seeking a highly skilled Regulatory Affairs Specialist to support the development and commercialization of novel implantable medical devices.

Job Description

This full-time opportunity involves working closely with the technical team to prepare and submit FDA pre-submissions, Investigational Device Exemptions (IDE), Pivotal Study applications, and Premarket Approval (PMA) submissions for Class III implantable devices.

Key Responsibilities:
  • Develop Regulatory Strategies: Ensure compliance with applicable regulations and standards for Class III implantable devices.
  • Lead Submission Preparation: Oversee the preparation and submission of FDA pre-submission documents, clinical trial protocols, and PMA applications.
  • Technical Documentation: Write, analyze, and edit technical documents to support country-specific regulatory submissions, ensuring consistency with applicable guidance documents.
  • Regulatory Guidelines: Review and interpret regulatory guidelines to ensure all submissions meet regulatory requirements.
  • Authorization Management: Update and maintain authorizations, manage renewals, device listings, and site registrations.
  • Collaboration: Work with engineering, preclinical, clinical, and quality assurance teams to gather necessary documentation and data for submissions.
  • Regulatory Input: Provide regulatory requirement inputs in developing technical and regulatory documents.
  • Response to Regulatory Authorities: Assist in preparing responses to regulatory authorities' questions within assigned timelines.
  • Assessing Regulatory Impact: Document the regulatory impact of product design changes in jurisdictions where the product is licensed.
  • Supporting Regulatory Agency Audits: Support external regulatory agency audits, providing regulatory input to minimize potential findings of non-compliance.
  • Maintaining Quality Procedures: Maintain quality procedures related to regulatory responsibilities, participate in internal audits, and support post-market surveillance activities.
Requirements

We are looking for a candidate with:

  • A minimum of 3 years of experience in regulatory affairs and/or quality assurance within a medical device organization.
  • Strong understanding of FDA regulations and guidance documents.
  • Proven experience in preparing IDE, clinical trial, and PMA submissions.
  • Excellent organizational skills and attention to detail.
  • Ability to work independently and as part of a collaborative team.
  • Strong communication and interpersonal skills.
  • Demonstrated ability to digest detailed data while maintaining a view of the big picture.
  • Strong data analysis skills.
  • Documented training on current medical device standards and regulations is an asset.
What We Offer

In this role, you will have the opportunity to work with a talented team, develop your skills, and contribute to the success of Fluid Biomed Inc. The estimated salary for this position is $85,000 - $110,000 per year, depending on experience.

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