Regulatory Affairs Specialist

21 hours ago

Calgary AB, Canada Fluid Biomed Inc. Full time

This is a full-time opportunity to join the technical team of an early-stage company to support the development and commercialization of a novel implantable medical device. Fluid Biomed is an innovative medical device startup focused on developing a cutting-edge neurovascular stent to treat brain aneurysms and enhance patient outcomes worldwide.

Position Summary:

As a Regulatory Affairs Specialist, you will play a crucial role in the preparation and submission of 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 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 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 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. Stay abreast of regulatory procedures, guidance documents, standards, and changes in regulatory climate.
  • Maintain up-to-date knowledge of regulatory changes and industry trends.
  • Support creation of protocols and supporting documentation for early feasibility studies and clinical trials.
  • Experience with packaging regulations and labeling for the final product according to the target jurisdictions.

Education:

Minimum of Bachelor’s degree in Biological Sciences, Biochemistry, Chemistry, Toxicology, Pharmacy, Medicine, Engineering, Pharmacology or related field.

Qualifications:

  • Minimum 3 years 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 incumbent should be proactive and results-oriented with high attention to detail and strong project management and organizational skills.
  • Proficiency in MS Office applications, databases, and efficient online research.

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