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Regulatory Specialist

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Toronto, ON
Job Type
Oct 18, 2017
Job ID
As a Regulatory Specialist you will be an integral contributor to a small, dynamic, cross-functional team of technical, clinical, QA/RA, and marketing individuals devoted to developing surgical imaging products
Your main areas of responsibility will be ensuring product development activities are aligned to support regulatory submissions, the regulatory submissions themselves, regulatory aspects of clinical studies, and regulatory review of marketing material. Day to day duties will include working with the broader development team to draft, compile, and review design history file documentation, reviewing clinical and marketing documents, and evolving company’s regulatory strategy as new information arises. The successful candidate will operate with a ‘startup’ mindset and is energized by the idea of working closely with a small team of other like minded people.
Major Responsibilities:
  • Active participant in all stages of design, development, V&V testing, design control activities, and production transfer, ensuring regulatory considerations and requirements met 
  • Prepare for and attend meetings with regulatory agencies (i.e. FDA pre-sub), as required
  • Prepare and submit FDA 510(k) application and CE Marking Technical File
  • Participate in the review of product requirements, design requirements, software requirements specifications, and functional specifications
  • Participate in Risk Management activities, FMEAs and ensure compliance to standards and regulations
  • Work with commercial team to ensure marketing and promotional material is aligned with regulatory clearances
  • Provide regulatory sign-off on all Design History File, clinical study, and marketing documentation
  • Ensure verification and validation protocols align with regulatory needs
  • Review clinical study documentation, including IRB / REB protocols
  • Review marketing and promotional material to ensure alignment with regulatory clearances

Minimal Qualifications:
  • Prior experience compiling and submitting an FDA 510(k) submission is required
  • 3-5 years of experience with FDA and/or ISO 13485-compliant quality management systems for Class II or Class III medical devices
  • Demonstrated success within a start-up, entrepreneurial work environment
  • Fluent in computer skills and, at a minimum, the use of Microsoft Office Word, Microsoft Office Excel, and Microsoft Office PowerPoint

Highly Desired Qualifications:
  • Has led or participated in CE marking and Health Canada submissions
  • Has led or participated in meetings with regulatory agencies
  • Education or experience in medical imaging devices
  • Experience working in a small team or start-up environment
  • Demonstrated project management skills and experience.
  • Proficient in timely review of technical and clinical data.
  • Exceptional problem solving skills and ability to “think outside the box”
  • Self-motivated and self-directed
  • Ability to handle and prioritize multiple tasks


KNG gets high demand for professionals in R&D, Engineering, Chemistry, Science and technology, manufacturing, Quality, Regulatory affairs, Process, and Facilities.

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