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Regulatory Affairs Specialist

Perimeter Medical Imaging

Perimeter Medical Imaging

Remote · United States
Posted on Wednesday, April 5, 2023


Perimeter Medical Imaging AI is a medical technology company driven to transform cancer surgery with its ultra-high resolution imaging technology to achieve our mission of advancing the standard of care, improving patient outcomes, and reducing healthcare costs. Our ultra-high-resolution, real-time, advanced imaging tools address areas of high unmet medical need.

With headquarters in Toronto, Canada and U.S. headquarters in Dallas, Texas, Perimeter Medical Imaging (TSXV:PINK)(FSE:4PC) has launched the next generation of imaging technology that allow surgeons to visualize microscopic tissue structures with unparalleled clarity in the operating room.

Job Description

Reporting to the Regulatory Affairs Director, the Regulatory Affairs Specialist will manage pre-market/post-market regulatory projects from beginning to end while ensuring alignment between regulatory requirements, business objectives, and corporate values. This position requires an advanced understanding of medical devices and their use, as well as an understanding of the regulatory submissions process. The main purpose of this position is to help assure compliance with the medical device regulations set forth by the FDA, Health Canada, and EU authorities.

Major Responsibilities

  • Support compliance within all facilities and target markets (emphasis on U.S. and Canada)
  • Prepare regulatory submissions and actively participate in the management of submissions for marketed products to fulfill U.S., Canadian, and EU regulatory requirements
  • Keep up to date with all state, provincial, and federal regulations through maintaining a robust regulatory intelligence process
  • Support the compliance of SOPs with applicable regulations
  • Serve as Regulatory Affairs Subject Matter Expert on cross-functional teams for product change control and regulatory interpretation
  • Build relationships with Regulatory Agencies
  • Support pre-market authorizations for new or modified medical devices, including regulatory strategy, submission preparation, regulatory communications, and recordkeeping
  • Perform reviews of pre- and post-market labeling, advertising, and promotional materials under strict guidelines and keep proper documentation
  • Support Clinical Affairs activities, including IRB approvals, clinical trial applications (eg, IDE), and maintaining records in
  • Coordinate market actions and incident reporting to local authorities
  • Liaising with various internal and external groups to collect necessary documents/information for compliance
  • Support internal and external audits

Essential Qualifications & Skills

  • Knowledge of FDA, Health Canada, and EU Medical Device regulations is required
  • Minimum 5 years experience in Medical Devices regulations, software and artificial intelligence experience is a plus
  • Reliable, accountable, detail oriented
  • Organized, very good judgment, and decision-making skills
  • Excellent communications skills

The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.

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To apply for this role, please email us your resume and (optional) cover letter with “Regulatory Affairs Specialist” in the subject line to: [email hidden]

Perimeter Medical Imaging AI is an equal opportunity employer and supports workforce diversity. Perimeter welcomes and encourages applications from people with disabilities. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

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