Regulatory Affairs Expert

7 days ago

Calgary, Alberta, Canada Fluid Biomed Inc. Full time

**Job Summary**

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Fluid Biomed Inc. This is a full-time opportunity to contribute to the development and commercialization of novel implantable medical devices.

About Us

Fluid Biomed Inc. is an innovative medical device startup focused on developing cutting-edge neurovascular stents to treat brain aneurysms and enhance patient outcomes worldwide.

Your Role

In this key position, you will play a crucial role in preparing and submitting FDA pre-submissions, Investigational Device Exemptions (IDE), Pivotal Study applications, and Premarket Approval (PMA) submissions for Class III implantable devices.

Main Responsibilities

  • Develop regulatory strategies for Class III implantable devices, ensuring compliance with applicable regulations and standards.
  • Lead the preparation and submission of FDA pre-submission documents, clinical trial protocols, and PMA applications.
  • Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents.
  • Review and interpret regulatory guidelines, ensuring all submissions meet regulatory requirements.
  • Update and maintain authorizations (e.g., IDEs, 510(k)s, Canadian licenses, CE dossiers) and manage renewals, device listings, and site registrations.
  • Collaborate with engineering, preclinical, clinical, and quality assurance teams to gather necessary documentation and data for submissions.
  • Collaborate with the team to provide regulatory requirement inputs in developing technical and regulatory documents (e.g., SSED as well as verification test methods and protocols).
  • Assist in preparing responses to regulatory authorities' questions within assigned timelines.
  • Assess and document regulatory impact of product design changes in jurisdictions where the product is licensed.
  • Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
  • Maintain quality procedures related to regulatory responsibilities, participate in internal audits, and support post-market surveillance activities.
  • Coordinate with external consultants and regulatory agencies as needed.

Requirements

To be successful in this role, you will need:

  • A minimum of Bachelor's degree in Biological Sciences, Biochemistry, Chemistry, Toxicology, Pharmacy, Medicine, Engineering, Pharmacology or a related field.
  • Minimum 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.
  • Excellent written and verbal communication skills with the ability to listen, articulate, and advocate.
  • Documented training on current medical device standards and regulations is an asset (e.g. MDSAP, EU MDR, ISO 13485, etc.).
  • Demonstrated skill at managing multiple projects and deadlines.
  • Ability to work effectively in a demanding environment with strict timelines and operating procedures.

Additional Attributes

The ideal candidate should possess high attention to detail, strong project management and organizational skills, and proficiency in MS Office applications, databases, and efficient online research.

Salary Range

$120,000 - $150,000 per annum, depending on qualifications and experience.

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